Endoluminal tool deployment system

ABSTRACT

Systems, devices and methods are provided for endoscopic procedures involving tissue manipulations beyond the capabilities of traditional endoscopic instruments. Embodiments of the systems include an elongated main body having a scope therethrough. Some embodiments of the systems include an elongated main body which is rigidizable and/or torque transmitting to improve manipulation through passageways in the body.

CROSS-REFERENCES TO RELATED APPLICATIONS

[0001] This application is a continuation-in-part of, and claims thebenefit of priority from co-pending U.S. patent application Ser. No.10/346,709, filed Jan. 15, 2003, and also claims the benefit of priorProvisional Application No. 60/______, filed on May 19, 2003, the fulldisclosures of which are hereby incorporated herein by reference.

STATEMENT AS TO RIGHTS TO INVENTIONS MADE UNDER FEDERALLY SPONSOREDRESEARCH OR DEVELOPMENT

[0002] NOT APPLICABLE

REFERENCE TO A “SEQUENCE LISTING,” A TABLE, OR A COMPUTER PROGRAMLISTING APPENDIX SUBMITTED ON A COMPACT DISK.

[0003] NOT APPLICABLE

BACKGROUND OF THE INVENTION

[0004] The present invention relates generally to medical devices,systems and methods. More particularly, the present invention relates todevices, systems and methods for use in endoscopic or laparoscopicprocedures.

[0005] Endoscopy is a form of minimally invasive procedure wherein theinterior of the body is accessed and visualized through an orifice inthe body, such as the esophagus or rectum. Such access allows a surgeonor physician to view and/or treat internal portions of the orifice orinternal tissues or organs which are accessible through the orifice.These procedures may be for diagnostic purposes, such as visualinspection or the removal of a tissue sample for biopsy, or theprocedure may be used for treatment purposes, such as the removal of apolyp or tumor or the restructuring of tissue. While these procedurescan be done using regular open surgery, endoscopy usually involves lesspain, less risk, less scarring, and faster recovery of the patient.

[0006] Endoscopy is typically performed with the use of an endoscope, asmall circular tube containing optical components. Traditionalendoscopes comprise a small diameter “snake-like” insertion tube havinga distal end which is inserted into the orifice to the desired internallocation. Fiber optics extend through the insertion tube and terminateat the distal end to allow axial viewing from the distal end. Images ofthe internal location near the distal end of the endoscope aretransmitted to a video monitor for the physician to view. A controlhandle allows the endoscopist to control the direction of the scope andin some cases, permits the actuation of air, water and suction utilitiesthat may be required for the endoscopy procedure.

[0007] Since endoscopes may be used to perform a treatment at aninternal location, some endoscopes are equipped with a lumen throughwhich a surgical instrument or tool may be passed. Generally, the lumenextends through the length of the insertion tube to the distal end sothat the end effector of the inserted instrument protrudes from thedistal end in the axial direction. Thus, the instrument is directed inparallel to the fiber optics so that the end effector is positionedalong the line of view.

[0008] Such endoscopes have a number of constraints which limit theirusefulness in performing diagnostic and surgical procedures. To begin,surgical instruments and tools are inserted axially through a workinglumen in the endoscope. And, most of these endoscopes only allow axialand rotational movement of the tool beyond the distal end. This helps tomaintain positioning of the tool within the field of view of theendoscope which is also directed axially. However, this limits thevariety and complexity of procedures that may be performed. For example,procedures which involve tissue approximation pose great difficultysince only one portion of tissue may be grasped at a time and lateral,rather than axial, movement may be required. Although steering of anaxially inserted tool may be possible near the distal end, such steeringtypically positions the end effector of the tool out of the field ofview of the axially directed scope.

[0009] A similar minimally invasive procedure which overcomes some ofthese constraints is laparoscopy. In laparoscopy, the interior of thebody is accessed and visualized through a small incision. When accessingthe abdomen, the incision is usually made in the navel. Laparoscopy wasinitially used by gynecologists to diagnose and treat conditionsrelating to the female reproductive organs: uterus, fallopian tubes, andovaries. It is now used for a wider range of procedures, includingoperations that in the past required open surgery, such as removal ofthe appendix (appendectomy) and gallbladder removal (cholecystectomy).Laparoscopy is performed with a device which allows the surgeon orphysician to view and/or treat internal tissues or organs which areaccessible through the incision. This device is the same or similar toan endoscope, sometimes referred to as a laparoscope. The devicecomprises a small diameter insertion tube having a distal end which isinserted into the incision to the desired internal location. Fiberoptics extend through the insertion tube and terminate at the distal endto allow axial viewing from the distal end. Images of the internallocation near the distal end are transmitted to a video monitor for thephysician to view. Sometimes, access through an incision creates ashorter, straighter and more direct access path than through an orifice.Therefore, some laparoscopes may have a shorter and stiffer insertiontube than some endoscopes.

[0010] Although laparoscopes suffer from many of the same limitations asendoscopes, laparoscopy allows additional surgical instruments and toolsto be inserted through separate incisions to perform procedures. Properlocation of the incisions can allow instruments to be positioned invarious directions. Therefore, movement and viewing is not limited tothe axis of the laparoscope and simultaneous viewing of the tissues andthe instruments may be more readily achieved during the procedure.However, these additional benefits are achieved at the cost of increasedinvasiveness. Access paths must be created for the instruments with theuse of trocars requiring general anesthesia, risk of complications andinfection, and increased overall recovery time for the access paths toheal. In addition, access may be difficult or contraindicated in somepatients, particularly in the morbidly obese.

[0011] Thus, it would be desired to provide an improved methods, devicesand systems to perform minimally invasive procedures. Particularly,methods, devices and systems which would provide the benefits ofendoscopy, such as lower invasiveness and access to deeply internallocations, with the benefits of laparoscopy, such as the use of multipleinstruments with movement and viewing along various axes. The devicesand systems would be reliable, convenient and easy to use with improvedoutcomes for patients due to reduction in invasiveness and thereforerisk, cost and recovery time. At least some of these objectives will bemet by the invention described hereinafter.

[0012] In addition, it would be desired to provide improved methods,devices and systems which would provide improve passage and manipulationthrough endovascular passageways. Typical endoscopes have a length inthe range of 130 to 190 cm and may be used to traverse a variety oftortuous paths within the body. For example, endoscopes may be used toaccess the lower gastrointestinal tract from entry through the anus,sometimes reaching as far as the cecum at the distal end of the colon.The upper gastrointestinal tract may be accessed through the esophagusto the stomach and the upper regions of the small intestine. Achievingaccess to any of these regions, particularly through the colon, involvestedious manipulation of the endoscope. Much of this manipulationinvolves torqueing of the endoscope. However, once a substantial lengthof the endoscope has passed into the body, torqueing becomesincreasingly difficult. In addition, accessing such regions usuallytakes place through minimally supported lumens, such as the colon, whichdo not provide resistive strength or through open cavities, such as thestomach, which do not provide particular pathways for the endoscope.This also limits the use of endoscopic access to desired treatmentlocations.

[0013] Thus, it would be desired to provide improved methods, devicesand systems to access desired treatment locations. Particularly,methods, devices and systems which would improve the ability to accessdesired treatment locations minimally invasively, particularlyendoscopically or laparoscopically. The devices and systems would bereliable, convenient and easy to use with improved outcomes for patientsdue to reduction in invasiveness and therefore risk, cost and recoverytime. At least some of these objectives will be met by the inventiondescribed hereinafter.

BRIEF SUMMARY OF THE INVENTION

[0014] The present invention provides systems, devices and methods forendoscopic procedures involving tissue manipulations beyond thecapabilities of traditional endoscopic instruments. Some embodiments ofthe systems include an elongated main body which is rigidizable and/ortorque transmitting to improve manipulation through passageways in thebody. And, some embodiments of the systems include an elongated mainbody having a scope therethrough and at least one steerable tool armwhich extends from the distal end of the main body. In theseembodiments, the system typically includes two tool arms, each armsteerable to form a curve laterally outward which then bends laterallyinward so that the arms form a an angular or boomerang shape. Inaddition, end effectors extend from the distal ends of each arm for usein manipulation of tissue. The angular shape brings the end effectorstogether in view of the scope for cooperative movements which arecontinuously visible by the surgeon through the scope. In addition, thetool arms may be steerable in any additional direction and may berotateable to allow grasping, pulling, tugging, elevation and morecomplex manipulation of tissue. Thus, the systems and devices of thepresent invention provide many of the capabilities of open surgery orlaparoscopic surgery with an endoscopic approach. In addition, thesystems and devices of the present invention provide improvements inmanipulation for accessing desired treatment locations.

[0015] In a first aspect of the present invention, the tool arm(s)comprise a shaft having a proximal end and a deflectable or steerabledistal end. In some embodiments, the steerable distal end will belaterally stabilized so that the distal end may be steered, i.e. bent ormanipulated, within a plane but will resist deflection outside of theplane during use. The steering plane will generally be parallel to acentral axis of the scope but may be rotated by rotation of the toolarm. In this way, the arm(s) will maintain stable positioning within thefield of view of the scope and will resist accidental deflection outsideof the field. It may be appreciated that the tool arm may also betranslated axially within the stabilized plane while maintaining viewingwithin the field.

[0016] A preferred structure for achieving lateral stability comprises aplurality of adjacent links. Usually, the links are pivotally attachedby hinged structures. In some embodiments, the hinged structurescomprise pivot pins which are disposed parallel to one another andgenerally transverse to the stabilized plane in which the arm may besteered. In other embodiments, the hinged structures comprise male andfemale bearing surfaces which define axes, wherein the axes are disposedin parallel to limit deflection of the distal section to within theplane. A variety of other structures are also available to providelateral stability, such as deployment frames, various shaped linkagesconnected by reinforcements or pullwires, and slotted tubes, to name afew.

[0017] Typically, the distal end includes at least two steerablesections, wherein a distal-most steerable section includes a tip sectionwhich curves in a first direction and wherein an intermediate steerablesection includes a base which curves in the opposite direction, whereboth curves are in the stabilized plane. In some embodiments, the tipsection curve has a radius which is greater than that of the curve ofthe base. To achieved such curvatures, the adjacent links may be shapedto allow substantially continuous deflection. Or, the adjacent links maybe shaped so that the steerable distal end is deflectable to form apredetermined curvature wherein the arm is then restricted from furtherdeflection.

[0018] Means for selectively deflecting the distal section of the toolarm(s) often comprise at least one pullwire or one pushwire. Such pullor pushwires may be present in any quantity and arrangement. The meansfor selectively deflecting the distal section can further include atleast one spring which is configured to straighten the distal section inopposition to the pullwire or pushwire.

[0019] In some embodiments, the tool arm includes an end effectordisposed at its distal end. A wide variety of end effectors may be useddepending on the procedure or tissue manipulations which are desired.For example, end effectors may include but are not limited to knives,needles, sutures, staplers, fasteners, clippers, electrosurgical orhemostatic cutters and coagulators, laser welders, cryosurgeryinstruments, secondary scopes, forceps, lasers hooks, tongs, graspers,retractors, probes, clamps, scissors, tissue approximation devices andsuction applicators. Alternatively, the tool arm may include a tooldeployment lumen through which a tool having an end effector may bepassed. In these embodiments, the tool arm may include a steering cuffarranged for passage of the tool therethrough so that manipulation ofthe tool within the steering cuff steers the distal end of the tool arm.Thus, in either case, manipulation of the end effector and the tool armmay be interconnected.

[0020] In another aspect of the present invention, the elongated mainbody has a distal end, a proximal end, and an arm guide lumen extendingthrough at least a distal section of the elongated main body. Inpreferred embodiments, the elongated main body has a viewing or scopelumen extending therethrough and terminating in the distal tip. It maybe appreciated that the scope lumen may be used for passage of anyviewing element or device or the scope lumen may comprise a viewingelement or device fixed or integrated within the main body. Herein, itwill be assumed that the term “scope lumen” will be used to refer toeither of these embodiments.

[0021] The arm guide lumens and the viewing scope lumen may be arrangedin any suitable fashion within the main body. For example, when theelongated main body has a second arm guide lumen, the distalterminations of the two arm guide lumens and the one viewing scope lumenmay be arranged in a generally triangular pattern on the distal tip ofthe main body. Alternatively, the lumens may be aligned, wherein theviewing scope lumen is disposed between the arm guide lumens.

[0022] Typically, at least the distal section of the elongated main bodyis steerable. In some embodiments, the elongated main body comprises afirst section and a second section, the first section disposedproximally of the second section, and the first and second sections areindependently lockable. Thus, the first section may be lockable whilethe second section remains steerable. Such steering may be achieved withmeans for selectively deflecting the second section within at least asingle plane. This may include retroflexion wherein the distal end ofthe main body is directed toward the proximal end. In some embodiments,the distal section of the elongated main body comprises a plurality ofadjacent links to allow for such steering.

[0023] Typically, at least the distal section of the elongated main bodyhas a generally cylindrical exterior wherein the arm guide lumen doesnot extend out of the cylindrical exterior. And, the arm guide lumenterminates at a distal tip of the elongated main body so that the toolarm advances through the distal tip. Likewise, as mentioned previously,the elongated main body typically has a viewing scope lumen extendingtherethrough and terminating in the distal tip.

[0024] In yet another aspect of the present invention, the tool arms mayhave a distal end which is steerable by a variety of mechanisms. Forexample, the distal end may be comprised of a flexible tube having atleast one pullwire attached thereto so that manipulation of the at leastone pullwire deflects the steerable distal end. Or, the tool arm mayhave a steerable distal end which comprises a flexible tube having shapememory material so that emergence of the steerable distal end from thedistal tip of the main body allows deflection of the steerable distalend to a shape memory position. Or, the tool arm may further comprise adeployment frame extending from the distal tip of the main body, theframe comprising at least two supports each attached to one of the atleast two tool arms so that manipulation of the deployment framedeflects the attached tool arms.

[0025] In an additional embodiment of the present invention, theendoluminal tool deployment system may be comprised of an elongated mainbody having a distal end, a proximal end, and at least two arm guidelumens extending over or through at least a distal section of theelongated main body, wherein said arm guide lumens extend fully to adistal tip of the main body, and at least two tool arms adapted toextend through the arm guide lumens of the elongated main body, saidtool arms emerging from the distal tip of the main body.

[0026] In still another aspect of the present invention, the endoluminaltool deployment system comprises an elongated main body having a distalend, a proximal end, and an arm guide lumen extending through at least adistal section of the elongated main body, wherein at least the distalsection comprises a plurality of adjacent links. The system furtherincludes a means for selectively deflecting the distal section within atleast a single plane, and at least one tool arm adapted to extendthrough the arm guide lumen of the elongated main body.

[0027] In a further aspect of the present invention, a method isprovided for deploying one or more tools in an anatomical space. In apreferred embodiment, the method comprises introducing a distal end of amain body to said anatomical space, advancing a tool arm from a tooldeployment lumen in said main body into said anatomical space,deflecting and positioning the tool arm to locate a distal tip thereofadjacent to a target location within the anatomical space, wherein adistal section of the arm is curved and laterally stabilized in a singleplane, and advancing a tool through a lumen of the tool arm to thetarget location.

[0028] In some embodiments, deflecting and positioning comprisestensioning a plurality of adjacent hinged links within the distalsection of the tool arm. The adjacent hinged links may be joined byhinge pins which are disposed perpendicularly to the single plane suchthat the pins stabilize the distal section and inhibit deflectionoutside of the single plane. The method may further comprise viewing thetarget location through a viewing scope disposed in the main body,wherein the tool arm extends axially from a distal tip of the main bodyfrom a location adjacent to the viewing scope.

[0029] In some embodiments, an endoluminal system is provided comprisingan elongated main body having a proximal end, a distal end sized forpassage through a body lumen, and at least one lumen extending betweenthe proximal and distal ends. The system further includes a torquetransmitting feature which provides torque transmission between theproximal and distal ends while the main body is unlocked and able toform a desired configuration. In addition, the system includes a lockingmechanism which locks the main body in the desired configuration. The atleast one lumen may be used for passage of any desired device,including, for example, a viewing scope and optionally one or more toolarms. In addition, the system typically includes a steering mechanismwhich steers the main body to the desired configuration while the mainbody is unlocked. In most embodiments, the steering mechanism comprisesat least one pullwire extending through the plurality of adjacent links.

[0030] In preferred embodiments, at least a portion of the elongatedmain body comprises a plurality of adjacent links. Torque may betransmitted through the adjacent links by a variety of torquetransmitting features. For example, in some embodiments, when theplurality of adjacent links comprises at least a first link and anadjacent second link, the torque transmitting feature comprising atleast one protrusion or tooth from the first link slidably engageablewith at least one groove in the adjacent second link, the torquetransmitting feature providing torque transmission through the portionof the main body while the links are rotateable. In some embodiments,the at least one protrusion comprises a pair of protrusions, eachprotrusion extending outwardly from an outer surface of the first linkin a diametrically opposite position from the other protrusion.Correspondingly, the at least one groove may comprise a pair of grooves,each groove configured to accept one or the pair of protrusions passingtherein. When the first link comprises a first domed ring having theouter surface and the adjacent second link comprises a second domed ringhaving an inner surface, the outer surface of the first domed ring ismateable with the inner surface of the second domed ring along alongitudinal axis, and the rings are rotateable away from thelongitudinal axis. In some embodiments, each groove comprises a firstgroove end and a second groove end, the groove ends substantiallyaligned with the longitudinal axis to allow sliding of the protrusionsalong the grooves during rotation of the rings away from thelongitudinal axis. It may be appreciated that such protrusions mayextend inwardly from an inner surface and the grooves may be disposed onthe outer surface of an adjacent link to accept such protrusions. Thus,the protrusions and associated grooves may function in a similar mannerin an inverse arrangement.

[0031] In other embodiments, the torque transmitting feature comprises aprotrusion or a pin from the first link slidably engageable with a slotin the adjacent second link. This is an example of a torque transmittingfeature which provides torque transmission by preventing disengagementof the adjacent links while the main body is unlocked and able to form adesired configuration. In some embodiments, the plurality of adjacentengageable links comprises at least a first link and an adjacent secondlink and the torque transmitting feature comprising at least one pinfrom the first link slidably engageable with at least one slot in theadjacent second link. Further, in some embodiments, the at least one pincomprises a pair of pins, each pin extending outwardly from an outersurface of the first link in a diametrically opposite position from theother pin. Similarly, the at least one slot comprises a pair of slots,each slot configured to accept one or the pair of pins passingtherethrough.

[0032] In preferred embodiments, the first link comprises a first domedring having the outer surface and the adjacent second link comprises asecond domed ring having an inner surface, the outer surface of thefirst domed ring being mateable with the inner surface of the seconddomed rings along a longitudinal axis, and the rings being rotateableaway from the longitudinal axis. Typically, each slot comprises anelongate opening between a first slot end and a second slot end, theslot ends substantially aligned with the longitudinal axis to allowsliding of the pins through the slots during rotation of the rings awayfrom the longitudinal axis. It may be appreciated that such pins mayextend inwardly from an inner surface and extend through slots onadjacent links. Thus, the pins and associated slots may function in asimilar manner in an inverse arrangement.

[0033] In yet other embodiments, the torque transmitting featurecomprises a torque transmitting covering over the plurality of adjacentengageable links to prevent disengagement of the adjacent links. In someinstances, the torque transmitting covering comprises a snuggly fitsheath including reinforcements, such as a braided material. Thereinforcements may comprise nylon, polyurethane, polyethylene, Teflon,metal, or polymer, for example. Optionally, the reinforcements may becoated with a polymer or the reinforcements may be covered with aseparate polymer component. Alternatively, the torque transmittingcovering may comprise a polymer coating over the links themselves.

[0034] In still further embodiments, an endoluminal device is providedcomprising an elongated main body having a proximal end, a distal end,and at least one lumen extending between the proximal and distal ends,at least a portion of the elongated main body comprising at least afirst link and an adjacent second link which are rotateable relative toeach other when unlocked, one of the at least one lumen extendingthrough the links having at least one partition. An elongated shaft ispresent passing through one of the at least one lumen in a manner totransmit torque by contacting the least one partition. In addition, alocking mechanism is provided which locks the links upon actuation bypreventing rotation of the links relative to each other.

[0035] In some embodiments, the at least one partition comprises aninward protrusion. And, the at least one lumen extending through thelinks may have a fluted shape forming the inward protrusions. In otherembodiments, the at least one partition comprises a divider spanningacross the one of the at least one lumen. The shaft passes through theat least one lumen and is positioned between partitions in each of thelinks. Torqueing of the plurality of adjacent links is transmittedthrough the shaft and partitions. For example, by applying torque to afirst link, the first link rotates about the longitudinal axis until theshaft contacts a partition. Since the partitions are generally aligned,the shaft will also contact partitions in a second link. Therefore,torque is transmitted from the first link to the second link. Thistransmission may be repeated through any number of links, transmittingtorque through a plurality of adjacent links.

[0036] In additional embodiments, the torque transmitting featurecomprises an oval shape of the plurality of adjacent links. And, inother embodiments, the torque transmitting feature comprises a pluralityof wires or rods extending through the adjacent links. In preferredembodiments, the plurality of rods comprises approximately 8 to 64 rods.Torque is transmitted from link to link through these torquetransmitting features.

[0037] Further, a method of accessing is provided comprising providingan elongated main body having a proximal end, a distal end, avisualizing element and a locking mechanism, wherein the main body iscapable of forming a desired configuration in an unlocked state andholding the desired configuration in a locked state. The method furtherincludes introducing the main body through a body passageway in theunlocked state forming the desired configuration so that the distal endreaches a target location, actuating the locking mechanism to hold themain body in the desired configuration, and viewing the target locationwith the use of the visualizing element.

[0038] Introducing the main body may comprise allowing the main body toassume a shape of the body passageway in the unlocked state forming thedesired configuration. Or, introducing the main body may comprisesteering the main body through the body passageway in the unlocked stateforming the desired configuration. In either situation, in someembodiments, the main body comprises a plurality of adjacent links sothat actuating the locking mechanism comprises holding the links in afixed relation to each other. In particular, the plurality of adjacentlinks sometimes comprises a plurality of nestable elements so thatholding the links comprises wedging the links together to hold them byfriction.

[0039] When the main body includes at least one lumen extending betweenthe proximal and distal ends, the method may further compriseintroducing an instrument through the at least one lumen. In someembodiments, the instrument comprises a tool arm. When the elongatedmain body further includes a visualizing lumen and the visualizingelement comprises an endoscope, the method may further comprisepositioning the endoscope within the visualizing lumen.

[0040] Other objects and advantages of the present invention will becomeapparent from the detailed description to follow, together with theaccompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0041]FIG. 1 illustrates an embodiment of a system of the presentinvention.

[0042]FIG. 2 illustrates the system of FIG. 1 in an assembledarrangement.

[0043]FIG. 2A depicts the cross-section of the system of FIG. 2, andFIG. 2B depicts an alternative cross-section.

[0044] FIGS. 3A-3D, 4-6 illustrate possible movements of the steerabledistal ends of the tool arms.

[0045] FIGS. 7A-7B illustrate the use of an embodiment of the system toperform a mucosectomy.

[0046] FIGS. 8A-8C illustrate an embodiment of the main body in avariety of positions.

[0047]FIG. 9A shows an embodiment of the shaft of the main bodycomprised of a multiplicity of nestable elements, and FIG. 9B providesan exploded view of these elements.

[0048] FIGS. 9C-9E provide cross-sectional views of various nestableelements.

[0049]FIG. 10A provides an exploded view of nestable elements having apullwire extending through their centers and FIG. 10B provides across-sectional view one of the nestable elements.

[0050]FIG. 10C illustrates the nestable elements of FIG. 10A with theinclusion of liners and FIG. 10D provides a cross-sectional view of oneof the nestable elements.

[0051] FIGS. 10E-100 illustrate embodiments of the main body.

[0052]FIG. 11 illustrates an embodiment of a tool arm.

[0053] FIGS. 12A-12B, 13A-13B, 14 illustrate embodiments of adjacentlinks disposed at the distal end of a tool arm.

[0054]FIG. 15 illustrates examples of possible deflections or movementsof an embodiment of the tool arm.

[0055] FIGS. 16A-16B illustrate another embodiment of a tool armcomprising a plurality of adjacent links.

[0056] FIGS. 17, 17A-17C illustrate an embodiment of a tool arm which issteerable to a predetermined arrangement.

[0057] FIGS. 18A-18B illustrate the creation of distinct curvaturesachieved by separate pullwires.

[0058]FIG. 19 illustrates two tool arms steered to a predeterminedarrangement.

[0059]FIG. 20 illustrates an embodiment including both links which aresteerable to a predetermined arrangement and links which areunrestrictedly steerable.

[0060] FIGS. 21A-21B illustrate an embodiment of a tool arm comprised ofa slotted tube.

[0061] FIGS. 21C-21D illustrate an embodiment of a tool arm comprised ofa tube wherein a pullwire is positioned on the outside of the tube.

[0062] FIGS. 21E-21F illustrate an embodiment of a tool arm comprised ofa polymer wall co-extruded with shape memory material.

[0063] FIGS. 21G-21H illustrate a mechanism for steering the tool armsincluding a deployment frame.

[0064] FIGS. 22A-22B, 23, 24 illustrate embodiments of the shaft of themain body.

[0065] FIGS. 25A-25B provide a view of the proximal end of an embodimentof the main body wherein two tool arms are present, each including asteering cuff.

[0066] FIGS. 26, 27A-27B, 28A-28B illustrate embodiments of a steeringcuff.

[0067] FIGS. 29, 29A-29D illustrate embodiments of a tool having an endeffector in the form of various types of scissors.

[0068]FIG. 30 illustrates an embodiment of the tool having an endeffector in the form of gator toothed graspers.

[0069]FIG. 31 illustrates an embodiment of the tool having an endeffector in the form of an articulatable grasper.

[0070] FIGS. 32-36 illustrate embodiments of the tool having endeffectors in the form of various shaped retractors.

[0071] FIGS. 37A-37B illustrate grasping hooks inserted throughauxiliary lumens in the main body and FIG. 37C illustrates a fixationdevice which may be deployed by the tool arms when such grasping hooksare used in a plication procedure.

[0072]FIGS. 38, 39, 40A-40B illustrate alternative tools passed throughauxiliary lumens in the main body.

[0073]FIG. 41 illustrates a tool passed through an arm guide lumen foruse in conjunction with a tool arm.

[0074]FIG. 42 illustrates an arm used to cleanse a portion of the mainbody, particularly the scope lens.

[0075] FIGS. 43A-43F illustrate a torque transmitting feature utilizinga tooth and groove concept to maintain alignment of the plurality ofadjacent links at locations along its length.

[0076] FIGS. 44A-44D illustrate a torque transmitting feature utilizinga pin and slot concept to maintain alignment of the plurality ofadjacent links at locations along its length.

[0077] FIGS. 45A-45C illustrate the use of a torque transmittingcovering over the plurality of adjacent links providing torquetransmission therethrough while the links are rotateable.

[0078] FIGS. 46A-46D illustrate cross-sectional views of a link whereinone of the at least one lumen extending through the links has at leastone partition.

[0079] FIGS. 47A-47B illustrate a torque transmitting feature whereinthe links have an oval cross-section.

[0080] FIGS. 48A-48C illustrate a torque transmitting feature comprisinga plurality of rods extending through the adjacent links.

DETAILED DESCRIPTION OF THE INVENTION

[0081] I. Overview

[0082] An embodiment of a system 2 of the present invention isillustrated in FIG. 1. The system 2 includes an elongated main body 10having a proximal end 12 and a distal end 14 terminating in a distal tip16. The main body 10 is used to access an internal target locationwithin a patient's body. Typically, the distal end 14 is passed througha body orifice and one or more naturally occurring body lumens to thetarget location, such as in endoscopy, while the proximal end 12 remainsoutside of the body. Therefore, the main body 10 has a deflectableand/or steerable shaft 20, either due to choice of material or design ofthe shaft 20 to include links, hinges, coils or other similar structuresto allow deflection. Thus, FIG. 1 illustrates the main body 10 in adeflected position wherein the body 10 includes curvatures. Suchdeflection and/or steering may be useful in traversing body lumens tothe target location and is achievable by manipulation of a handle 22near the proximal end 12. It may be appreciated, however, that thesystem 2 may be used in laparoscopic procedures wherein such deflectionand/or steering may be less utilized for placement of the main body 10.In either case, rigidization of some or all the shaft 20 may be desired,for example to provide a stable visualization platform. Therefore,portions of the shaft 20 of the main body 10 are lockable to maintain adesired shape and provide rigidity, either due to choice of material ordesign of the shaft 20 to include locking mechanisms, as will bedescribed in later sections.

[0083] The main body 10 also includes at least one arm guide lumen 26which extends over or through at least a distal section of the main body10, typically along the majority of the length of the body 10 as shown.Here in FIG. 1, two arm guide lumens 26 are shown, each extending from aposition along the shaft 20 near the proximal end 12 to the distal tip16. In addition, the main body 10 includes a scope lumen 24 whichextends through the shaft 20 to the distal tip 16.

[0084] The system 2 also includes at least one tool arm 30, two areshown in FIG. 1, each arm 30 of which is insertable through a separatearm guide lumen 26 as indicated by dashed line. Each tool arm 30 has aproximal end 32, a distal end 34 and a shaft 36 therebetween. The distalend 34 is steerable, such as by manipulation of adjacent links asschematically indicated. Such steerability may be controlled by asteering cuff 35 which is part of the proximal end 32. The shaft 36 istypically flexible or deflectable to allow deflection of the surroundingmain body shaft 20. Each tool arm 30 additionally includes a tooldeployment lumen 38 therethrough.

[0085] In this embodiment, the system 2 also includes at least one tool40, two are shown in FIG. 1. Each tool 40 includes a distal end 42, aproximal end 44 and an elongate shaft 46 therebetween to allow passagethrough the tool deployment lumen 38 of the arm 30. Each tool 40 has anend effector 48 disposed at the distal end 42 and optionally a handle 50at the proximal end 44 for manipulation of the end effector 48 fromoutside the body. The tool 40 is advanced so that the end effector 48emerges from the distal end 34 of the arm 30.

[0086]FIG. 2 illustrates the system 2 of FIG. 1 in an assembledarrangement. Here, the tool arms 30 are shown inserted through the armguide lumens 26 of the main body shaft 20. The steerable distal ends 34of the arms 30 protrude from the distal end 14 of the main body 10 andthe proximal ends 32 of the arms 30 protrude from the proximal end 12 ofthe main body 10. As shown, the steering cuffs 35 are located at theproximal ends 32 of the arms 30. In addition, the tools 40 are showninserted through the tool deployment lumens 38 so that the end effectors48 extend beyond the steerable distal ends 34 of the arms 34. Likewise,the proximal ends 44 of the tools 40 with handles 50 are shownprotruding from the steering cuffs 35. Movement of the tools 40 againstthe steering cuffs 35 will actuate steering of the distal ends 34 of thearms 30, as will be described in later sections.

[0087]FIG. 2A provides a cross-sectional view of system 2 of FIG. 2.Since the shaft 20 of the main body 10 has a generally cylindricalexterior in this embodiment, the cross-section of the shaft 20 has acircular shape. It may be appreciated that cylindrical shafts mayalternatively have an elliptical, oval or oblong cross-section. Theshaft 20 has an outer diameter in the range of about 5 to 25 mm,preferably approximately 14 mm. The shaft 20 has a wall 21 with athickness in the range of about 0.5 to 5 mm, preferably about 2-3 mm,defining an inner central lumen 23. Within the wall 21 lies variouspushwires or pullwires 96, hereinafter referred to as pullwires, forsteering the main body 10 which may be present in a variety ofquantities and arrangements. Alternatively, the pullwires 96 may bepresent within the central lumen 23. At least one arm guide lumen 26,two are shown, extend through the central lumen 23. Each arm guide lumen26 has an inner diameter in the range of about 0.5 to 5 mm, preferablyabout 4 mm. Positioned within the lumens 26 are the shafts 36 of thetool arms 30. And, likewise, positioned within the shafts 36 are thetools 40. FIG. 2A also illustrates the scope lumen 24 which has an innerdiameter in the range of about 2 to 10 mm, preferably about 4 mm. Inthis embodiment, the two arm guide lumens 26 and the scope lumen 24 arearranged in a generally triangular pattern which is maintained to thedistal tip 16, however any suitable arrangement may be used which allowsviewing of the tool arms, particularly the end effectors, by the scope.For example, FIG. 2B illustrates a cross-section of an embodimentwherein the shaft 20 has an oval shape and the arm guide lumens 26 andthe scope lumen 24 are generally aligned. Here, the scope lumen 24 isdisposed between the arm guide lumens 26 to facilitate viewing of thetool arms 30. Also illustrated in FIGS. 2A and 2B are additional lumenswhich may be used for various needs. For example, an irrigation/suctionlumen 60, an insufflation lumen 56 and an auxiliary lumen 58 may bepresent, each having an inner diameter in the range of about 0.5 to 5mm, preferably about 2 mm. The auxiliary lumen 58 may be utilized for avariety of uses, such as insertion of additional tools, such as amacerator, a grasping tool, a cutting tool or a light source, to name afew, for use in conjunction with the end effectors present at the distalends of the arms 30 or the distal ends of the tools 40 inserted throughthe arms 30.

[0088] FIGS. 3A-3D illustrate a series of movements of the steerabledistal ends 34 of the tool arms 30. This series serves only as anexample, as a multitude of movements may be achieved by the distal ends34 independently or together. FIG. 3A illustrates the distal tip 16 ofthe main body 10. The scope lumen 24 is shown along with two arm guidelumens 26 terminating at the distal tip 16 and forming a triangularpattern as illustrated in FIG. 2A. FIG. 3B illustrates the advancementof the distal ends 34 of the tool arms 30 through the arm guide lumens26 so that the arms 30 extend beyond the distal tip 16. FIGS. 3C-3Dillustrate deflection of the arms 30 to a preferred arrangement. FIG. 3Cillustrates deflection of the arms 30 laterally outward. This isachieved by curvature in the outward direction near the base 64 of thesteerable distal end 34. FIG. 3D illustrates deflection of the tipsection 66 of the distal end 34 laterally inward achieved by curvaturein the inward direction so that each arm 30 forms a hook shape. Byfacing the tip sections 66 of the arms 30 toward each other as shown,the tip sections 66 are positioned directly in the path of the scopelumen 24. Therefore, when a scope 28 is positioned within the scopelumen 24, the tip sections 66 of the tool arms 30 and any tools 40advanced therethrough, will be visible through the scope 28. In FIGS.3C-3D, deflection of the arms 30 is achieved with the use of adjacentlinks 62 in the areas of desired curvature. Embodiments of such links 62and other mechanisms of deflection will be discussed in later sections.Further, the deflection of FIGS. 3A-3D are shown to be within a singleplane. However, various embodiments include deflection in multipleplanes. Likewise, the arms 30 are shown to be deflected simultaneouslyin FIGS. 3A-3D, however the arms 30 may be deflected selectively orindependently.

[0089] FIGS. 4-6 illustrate additional possible movements of the toolarms 30. For example, FIG. 4 illustrates axial movement of the tool arms30. Each tool arm 30 can independently move distally or proximally, suchas by sliding within the tool deployment lumen 38, as indicated byarrows. Such movement maintains the arms 30 within the same plane yetallows more diversity of movement and therefore surgical manipulations.FIG. 5 illustrates rotational movement of the tool arms 30. Each toolarm 30 can independently rotate, such as by rotation of the arm 30within the tool deployment lumen 38, as indicated by circular arrow.Such rotation moves the arm 30 through a variety of planes. By combiningaxial, lateral and rotational movement, the arms 30, and therefore thetools 40 positioned therethrough, may be manipulated through a widevariety of positions in one or more planes.

[0090]FIG. 6 illustrates further articulation of the tool arms 30. Insome embodiments, the arms 30 are deflectable to form a predeterminedarrangement, such as illustrated in FIG. 3D. Typically, when forming thepredetermined arrangement, the arms 30 are steerable up until theformation of the predetermined arrangement wherein the arms 30 are thenrestricted from further deflection. In other embodiments, the arms aredeflectable to a variety of positions and are not limited by apredetermined arrangement. Such an embodiment is illustrated in FIG. 6wherein the arms 30 articulate so that the tip sections 66 curl inwardlytoward the distal tip 16 of the main body 10. Again, the tip sections 66are positioned in front of the scope lumen 24 and scope 28 for viewing.Typically, the tip sections 66 a are positioned on opposite sides of acentral axis 31 of the scope 28, wherein the field of view (indicated byarrow 29) spans up to approximately 140 degrees, approximately 70degrees on each side of the central axis 31. In addition, the depth offield is typically in the range of approximately 1-10 cm.

[0091] As mentioned previously, the endoluminal tool deployment system 2of the present invention may be used to access a various internaltissues or organs to perform a wide variety of surgical procedures.FIGS. 7A-7B illustrate the use of an embodiment of the system 2 toperform a mucosectomy, or removal of a portion of the mucosa and/orsubmucosa of the stomach. FIG. 7A illustrates advancement of the mainbody 10 through the esophagus E to the stomach S. The main body 10 isthen steered to a desired position within the stomach S and the stomachmucosa M is visualized through the scope 28 at the distal tip 16.Referring to FIG. 7B, the tool arms 30 are then advanced through themain body 10 and articulated. As mentioned, tools 40 may be advancedthrough the tool arms 30 or an end effector 48 may be disposed at thedistal end of each arm 30. Here, a grasper 80 is disposed at the distalend of one arm 30 and a cutter 81 is disposed at the distal end of theother arm 30. The grasper 80 is used to grasp a portion of the mucosa M.The grasped portion of mucosa M can then be elevated by rotation ormanipulation of the tool arm 30. This allows safe resection of theportion of mucosa M by cutting with the use of the cutter 82, as shown.Manipulation and resection of the tissue is visualized throughout theprocedure through the scope 28 which is aligned with the tip sections66, and therefore end effectors 48.

[0092] It may be appreciated that the systems, methods and devices ofthe present invention are applicable to diagnostic and surgicalprocedures in any location within a body, particularly any natural orartificially created body cavity. Such locations may be disposed withinthe gastrointestinal tract, urology tract, peritoneal cavity,cardiovascular system, respiratory system, trachea, sinus cavity, femalereproductive system and spinal canal, to name a few. Access to theselocations may be achieved through any body lumen or through solidtissue. For example, the stomach may be accessed through an esophagealapproach, the heart through a port access approach, the rectum through arectal approach, the uterus through a vaginal approach, the spinalcolumn through a port access approach and the abdomen through a portaccess approach.

[0093] A variety of procedures may be performed with the systems anddevices of the present invention. The following procedures are intendedto provide suggestions for use and are by no means considered to limitsuch usage: Laryngoscopy, Rhinoscopy, Pharyngoscopy, Bronchoscopy,Sigmoidoscopy (examination of the sigmoid colon, the sigmoid colon isthe portion that connects the descending colon to the rectum; primarilyfor diagnostic purposes, however a biopsy procedure and trans anal microsurgery may be performed for removing tumors), Colonoscopy (examinationof colon; for the removal of polyps and tumors or for biopsy), andEsophagogastroduodenoscopy (EGD) which enables the physician to lookinside the esophagus, stomach, and duodenum (first part of the smallintestine). The procedure might be used to discover the reason forswallowing difficulties, nausea, vomiting, reflux, bleeding,indigestion, abdominal pain, or chest pain.

[0094] In addition, endoscopic retrograde cholangiopancreatography(ERCP) may be achieved which enables the surgeon to diagnose disease inthe liver, gallbladder, bile ducts, and pancreas. In combination withthis process endoscopic sphincterotomy can be done for facilitatingductal stone removal. ERCP may be important for identification ofabnormalities in the pancreatic and biliary ductal system. Othertreatments include Cholecystectomy (removal of diseased gallbladder),CBD exploration (for common bile duct stones), appendicectomy.(removalof diseased appendix), hernia repair TAP, TEPP and other (all kinds ofhernia), fundoplication and HISS procedures (for gastro esophagealreflux disease), repair of duodenal perforation, gastrostomy forpalliative management of late stage upper G.I.T. carcinoma), selectivevagotomy (for peptic ulcer disease), splenectomy (removal of diseasedspleen), gastric restrictive and malabsorbtive procedures (for morbidobesity), upper and lower G.I. endoscopies (diagnostic as well astherapeutic endoscopies), pyloroplastic procedures (for children'scongenital deformities), colostomy, colectomy, adrenalectomy (removal ofadrenal gland for pheochromocytoma), liver biopsy, gastrojejunostomy,subtotal liver resection, gastrectomy, small intestine partialresections (for infarction or stenosis or obstruction), adhesionsremoval, treatment of rectum prolaps, Heller's Myotomy,devascularization in portal hypertension, attaching a device to a tissuewall and local drug delivery to name a few.

[0095] II Main Body

[0096] As mentioned previously, the system 2 of the present inventionincludes an elongated main body 10 having a proximal end 12 and a distalend 14 terminating in a distal tip 16. The main body 10 may have avariety of features which are present in a variety of combinations.Generally, the features include deflectability, steerability,torqueability, lockability, lumens for the passage of visualizationelements, tool arms, and/or instruments, and integral visualizationelements, tool arms, and/or instruments, to name a few. In addition, themain body may have any of these features throughout any portion of themain body, including the entire length of the main body or individualsubportions.

[0097] One embodiment of the main body 10 is illustrated in FIGS. 8A-8C,9A-9D. In this embodiment, the main body 10 includes deflectabilityand/or steerability and lumens for the passage of visualizationelements, tool arms, and/or instruments, such as scope lumen 24. FIG. 8Aillustrates the main body in a straight configuration. Since the mainbody 10 is used to access an internal target location within a patient'sbody, the main body 10 has a deflectable and/or steerable shaft 20.Thus, FIG. 8B illustrates the main body 10 having various curvatures inits deflected or steered state. In preferred embodiments, the main body10 is steerable so that the main body 10 may be advanced throughunsupported anatomy and directed to desired locations within hollow bodycavities. In some embodiments, the main body 10 includes a first section90 which is proximal to a second section 92, as indicated in FIG. 8B.Although both sections 90, 92 are steerable, the first section 90 may belocked in place while the second section 92 is further articulated. Thisis illustrated in FIG. 8C, wherein the first section 90 is shown in alocked position unchanged from FIG. 8B and the second section 92 isshown in various retroflexed positions. In retroflexion, the secondsection 92 is curved or curled laterally outwardly so that the distaltip 16 is directed toward the proximal end 12 of the main body 10.Optionally, the second section 92 may also be locked, either inretroflexion or in any other position.

[0098] Steering and locking may be achieved by any suitable mechanisms.In some embodiments, the shaft 20 comprises a multiplicity of nestableelements 260, as illustrated in FIG. 9A. FIG. 9B provides an explodedview of the nestable elements 260 of FIG. 9A. Here it can be seen thatthe elements 260 are disposed so that a distal surface 262 of oneelement 260 coacts with a proximal surface 264 of an adjacent element.Each of the nestable elements 260 includes one or more pullwire lumens98 through which pullwires 96 pass. The pullwires 96 are used to holdthe elements 260 in nesting alignment and to provide steering andlocking. The pullwires 98 preferably are made from a superelasticmaterial, e.g. nickel titanium alloy, to provide flexibility,kink-resistance and smooth movement of the pullwires 96 through thepullwire lumens 98. Alternatively, the pullwires 96 may be made frombraided stainless steel, a single stainless steel wire,poly-para-phenylene terephthalamide (such as Kevlar®), a high tensilestrength monofilament thread, combinations thereof or any suitablematerials.

[0099] Generally, the adjacent surfaces 262, 264 are contoured to mateso that when the pullwires 96 are relaxed, surfaces 262, 264 can rotaterelative to one another. This allows the shaft 20 to form curvaturesthroughout its length in any direction. Each pullwire 96 is fixed at itsdistal end to a specific element 260 along the shaft 20 or to the distaltip 16. When tension is applied to a specific pullwire 96, a curvatureforms in the shaft 20 proximal to the fixation point, thus steering theshaft 20. The pullwires 96 may be arranged in various patterns toachieve steering in various directions. For example, FIG. 9C is across-sectional view of the shaft 20 in the first section 90 of FIG. 8B.Here, eight pullwires 96 (four pullwires 96 a and four pullwires 96 b)are shown passing through the wall 21. Four pullwires 96 a terminate atthe distal end of the first section 90 and are used to steer the firstsection 90. Since the pullwires 96 a are equidistantly positioned,applying tension to the pullwires 96 a, either individually or incombination, steers the first section 90 in any desired direction. Thefirst section 90 may be locked in place by holding the tension in thepullwires 96 a using any suitable mechanisms. For example, tension maybe applied to the pullwires 96 simultaneously until the elements 260 arecompressed to a state in which they are locked by friction wherein thetension is held.

[0100]FIG. 9D is a cross-sectional view of the shaft 20 in the secondsection 92 of FIG. 8B. Here, four pullwires 96 b are shown passingthrough the wall 21. These pullwires 96 b extended through the firstsection 90, as indicated in FIG. 9C, and terminate near the distal tip16. Since the pullwires 96 b are equidistantly positioned, applyingtension to the pullwires 96 b, either individually or in combination,steers the second section 92 in any desired direction. Since thepullwires 96 b also pass through the first section 90, such steering mayalso effect the curvature in the first section 90 when the first sectionis not locked. However, such effects are minimal, may be counteracted orcompensated for by steering in the first section 90, and may be avoidedby locking. The second section 92 may be also be locked in place byholding the tension in the pullwires 96 b using any suitable mechanisms.

[0101] In this embodiment, the wall 21 extends continuously from theproximal end 12 to the distal end 14 with the first and second sections90, 92 determined by the termination points of the pullwires 96 whichextend therethrough. Alternatively, the first and second sections 90, 92may be comprised of separate shafts which are coaxially positionedadjacent to one another.

[0102] In the embodiment illustrated in FIG. 9B, the nestable elements260 have a central lumen 23 which passes through the length of the mainbody 10. Instruments or tools may be passed through this lumen 23, asindicated in FIGS. 9C-9D, or tubes may be present within the lumen 23through which instruments or tools may be passed. In preferredembodiments, the nestable elements 260 have holes formed therein so thatlumens are formed by alignment of the holes when the elements 260 arestacked. For example, FIG. 9E provides a cross-sectional view of anestable element 260 illustrating the holes formed therein which serveas lumens. As shown, a scope lumen 24, arm guide lumens 26, andauxiliary lumens 58 extend through the center of the element 260 whilepullwire lumens 98 are located around the periphery.

[0103] It may be appreciated that pullwire lumens 98 may also extendthrough the center of the element 260. For example, FIG. 10A illustratesan embodiment having a pullwire 96 which extends through the center ofthe stacked nestable elements 260. FIG. 10A provides an exploded view ofthe nestable elements 260 wherein the elements 260 are disposed so thata distal surface 262 of one element 260 coacts with a proximal surface264 of an adjacent element. As shown, each of the nestable elements 260includes a pullwire lumen 98 through its center. FIG. 10B provides across-sectional view of a nestable element 260 of FIG. 10A. As shown,the nestable element 260 includes a locking pullwire lumen 98 c having apullwire 96 c therethrough in the center of the element 260 surroundedby various other lumens, such as a scope lumen 24, arm guide lumens 26,auxiliary lumen 58 and various pullwire lumens 98 used for steering.Once the elements 260 are positioned in a desired arrangement, the shaft20 may be locked in place by the central pullwire 96 c. Applying tensionto the pullwire 96 c compresses the elements 260 to a state in whichthey are locked by friction wherein the tension is held.

[0104] In addition, liners 266 may be passed through any of the lumensof the stacked nestable elements 260. Such liners 266 form create acontinuous lumen connecting the lumen holes of the nestable elements260. FIG. 1C illustrates the nestable elements 260 of FIG. 10A with theinclusion of liners 266 passing through, for example, the arm guidelumens 26. Likewise, FIG. 10D provides a cross-sectional view of anestable element 260 of FIG. 10C. Here, liners 266 are shown positionedthrough the nestable element 260 forming lumens 24, 26, 58 therethrough.It may also be appreciated that liners 266 may extend through pullwirelumens 98 as well. The liners 266 may be coated on their luminal surfacewith a hydrophilic coating for reducing friction or the liners 266 maybe comprised of a lubricious polymer such as Teflon®, fluoroethylenepolymer (FEP) or the like.

[0105] As mentioned previously, it may be appreciated that the shaft 20of the main body 10 may have a variety of structures to provide featuressuch as deflectability, steerability, torqueability, lockability,visualization and various tools, etc. Exemplary embodiments ofstructures which provide deflectability, steerability and or lockabilityare described above and provided in co-pending U.S. patent applicationSer. No. 10/281,462 filed Oct. 25, 2002, which is a continuation in partof U.S. patent application Ser. Nos. 10/173,203, 10/173,227, 10/173,238and 10/173,220, all of which were filed on Jun. 13, 2002 and hereinincorporated by reference for all purposes. Also of interest andincorporated by reference for all purposes are co-pending U.S. patentapplication Ser. Nos. 10/281,461 and 10/281,426 each filed on Oct. 25,2002. It is understood that lockablility includes locking the main bodyin a desired configuration to maintain one or more curvatures along itslength. Thus, in these instances the main body is shape lockable.Structures which provide torqueability will be described in latersections, however it is understood that these features are applicable toany of the embodiments described herein.

[0106] In addition, it may be appreciated that the main body 10 may becomprised of a traditional endoscope or laparoscope. Exemplaryembodiments of traditional endoscopes are provided in U.S. Pat. Nos.3,948,251; 4,036,218; 4,201,198; 4,224,929; 4,988,171; 5,020,539;5,035,231; 5,068,719; 5,170,775; 5,172,225; 5,187,572; and 5,196,928,all of which are herein incorporated by reference for all purposes. FIG.10E illustrates the shaft 20 of the main body 10 comprising atraditional endoscope 650, or other endoscope, which includes avisualizing element 652 and at least one light source 654. In thisembodiment, the endoscope 650 includes two arm guide lumens 26 for thepassage of tool arms 30. The tool arms 30 each have end effectors 48, asshown, or tools 40 which have end effectors 48 may be advanced through atool deployment lumen 38 in each arm 30. FIG. 10F provides across-sectional view of the shaft 20 of FIG. 10E. FIG. 10G illustratesthe shaft 20 of the main body 10 comprising a plurality of steerableand/or lockable nestable elements 260 and a traditional endoscope 650,or other endoscope, passing therethrough which includes a visualizingelement 652 and at least one light source 654. The endoscope 650 may beadvanceable and/or retractable through an endoscope lumen 656 in theshaft 20 of the main body 10 or may be fixed within the shaft 20. Theendoscope 650 may be positioned so that a distal end 658 of theendoscope 650 is flush with the distal tip 16 of the shaft 20 or isdisposed at any position along the shaft 20 including extending beyondthe distal tip 16, as shown. FIG. 10H provides a cross-sectional view ofFIG. 10G. Here, the wall 21 of the shaft 20 is more clearly visibleincluding pullwires 96 for steering and/or locking. Further, the shaft20 of the main body 10 may include one or more arm guide lumens 26 forthe passage of tool arms 30, as shown in FIG. 101. The tool arms 30 eachhave end effectors 48, as shown, or tools 40 which have end effectors 48may be advanced through a tool deployment lumen 38 in each arm 30. FIG.10J provides a cross-sectional view of FIG. 10I.

[0107]FIG. 10K illustrates the shaft 20 of the main body 10 having anintegral or integrated visualizing element 652 and at least one lightsource 654. Again, the shaft 20 comprising a plurality of nestableelements 260 for steering and/or locking. Optionally, the shaft 10 mayalso include a lumen 660, illustrated in FIGS. 10M-10N, for passage of avariety of tools, instruments or devices therethrough, including toolarms 30. Or, as shown in FIG. 10O, the shaft 20 having an integralvisualizing element and at least one light source 654 may haveindividual arm guide lumens 26 for the passage of tool arms 30. It mayalso be appreciated that the tool arms 30 of FIG. 10O may alternativelybe fixed or integral with the shaft 20.

[0108] The visualizing elements 652 of any of the embodiments includeelements which transmit and/or detect a visual image. For example, suchvisualizing elements 652 may include a coherent fiber optic bundle, anultrasound device, and/or charge coupled devices (CCD) for operation inthe visible spectrum of electromagnetic radiation, the infrared spectrumof electromagnetic radiation, the ultraviolet spectrum ofelectromagnetic radiation, and/or the x-ray spectrum of electromagneticradiation.

[0109] III Tool Arms

[0110] As mentioned previously, system 2 also includes at least one toolarm 30, each arm 30 of which is insertable through a separate arm guidelumen 26 in the main body 10. As shown in FIG. 11, each tool arm 30 hasa proximal end 32, a distal end 34 and a shaft 36 therebetween. Thedistal end 34 is steerable, such as by manipulation of adjacent links 62as schematically indicated. Such stecrability may optionally becontrolled by a steering cuff 35, disposed within the proximal end 32.Each tool arm 30 additionally includes a tool deployment lumen 38therethrough.

[0111] A. Distal End

[0112] FIGS. 12A-12B illustrate an embodiment of adjacent links 62disposed at the distal end 34 to allow steerability of the arm 30. Here,links 62 are pivotally connected by hinge structures 100. As shown inFIG. 12A, the links 62 are shaped so that connection by the hingestructures 100 creates gaps 102 between the links 62 directly oppositeto the hinge structures 100. A pullwire 96 is shown extending throughthe links 62 and terminating at a fixation point 104. Referring now toFIG. 12B, retraction of the pullwire 96 draws the links 62 together,minimizing the gaps 102 between the links 62. Due to the shape andarrangement of the links 62, this movement creates a curve in the arm 30as shown. The distal end 34 may be steered to have any curvature betweensubstantially straight and a maximum curvature wherein the gaps 102 arecompletely closed or another limiting feature is established. In someembodiments, up to 360 degree curvature of the distal end 34 ispossible. The distal end 34 may be returned to a straightened positionby advancement of the pullwire 96 or by the presence of a spring whichwill straighten the distal end 34 by recoil force.

[0113] FIGS. 13A-13B illustrate a similar embodiment of adjacent links62 disposed at the distal end 34 to allow steerability of the arm 30.Again, links 62 are pivotally connected by hinge structures 100.However, as shown in FIG. 13A, the links 62 are shaped so thatconnection by the hinge structures 100 creates gaps 102 between thelinks 62 on both sides of the hinge structures 100. A pullwire 96 isshown extending through the links 62 and terminating at a fixation point104. Referring now to FIG. 13B, retraction of the pullwire 96 draws thelinks 62 together, minimizing the gaps 102 between the links 62 alongthe pullwire 96 and maximizing the gaps 102 on the opposite side of thehinge structures 100. Due to this shape and arrangement of the links 62,this movement creates a curve in the arm 30 as shown. The distal end 34may also be returned to a straightened position by advancement of thepullwire 96 or by the presence of a spring which will straighten thedistal end 34 by recoil force. However, in this embodiment, the distalend 34 may be deflected or curved in the opposite direction by continuedadvancement of the pullwire 96. Advancement of the pullwire 96 minimizesthe gaps 102 on the opposite side of the hinge structures 100 causing acurvature in the opposite direction. Likewise, a spring may be presentto straighten the distal end 34 from a curvature in this oppositedirection.

[0114]FIG. 14 illustrates an embodiment similar to the embodimentillustrated in FIGS. 13A-13B. The links 62 are shown pivotally connectedby hinge structures 100. Here the hinge structures 100 comprise pivotpins 106 which are arranged in parallel to limit deflection to a singleplane. In some embodiments, the hinge structures comprise male andfemale bearing surfaces which define axes, wherein the axes are disposedin parallel to limit deflection of the distal section to within thesingle plane. The links 62 are shaped so that connection by the pivotpins 106 creates gaps 102 between the links 62. Closure of the gaps 102on one side of the pivot pins 106 simultaneously opens gaps on the otherside of the pins 106. FIG. 14 also illustrates an end effector 48 of atool 40 which has been advanced through the tool deployment lumen 38 ofthe arm 30.

[0115]FIG. 15 illustrates examples of possible deflections or movementsof the tool arms 30. Here, two arms 30 are shown emerging from thedistal tip 16 of the elongated main body 10. The distal end 34 of eacharm 30 is steerable and comprised of a plurality of adjacent links 62.The arm 30 on the left is shown steered to a position wherein the tipsection 66 is curled inwardly forming an almost complete circular shape.In contrast, the arm 30 on the right is shown steered to a positionwherein the tip section 66 is deflected slightly inwardly forming an arcshape. Thus, the arms 30 may be independently steerable to varyingdegrees of curvature. Preferably, the arms 30 are steerable inwardly toperform surgical procedures in cooperation and to maintain visibilitythrough the centrally located scope.

[0116] FIGS. 16A-16B illustrate another embodiment of a tool arm 30comprising a plurality of adjacent links 62. Here, the links 62 arecomprised of disks 110 having faces which are angled to form gaps 102between the disks 110 when the disks 110 are stacked. The disks 110 areconnected by one or more wires or ribbons 112. In this embodiment,illustrated in FIG. 16B, two ribbons 112 are present, each atdiametrically opposite positions within the wall of each of the stackeddisks 110 so that the angled faces are aligned between the ribbons 112.The ribbons 112 may be embedded in the wall, co-molded with the stackeddisks or simply advanced through a lumen in the wall. The ribbons 112maintain relative position of the disks 110 and stabilize the steerabledistal end 34 to be deflectable in only a single plane. Also shown inFIG. 16B, lumens 114 are present between the ribbons 112 for positioningpullwires 96 therethrough. The pullwires 96 pass through the angledportions of the disks 110 so that application of tension to a pullwire96 draws the angled faces of the disks 110 together to close the gaps102 therebetween. This in turn widens the diametrically opposite gaps102 creating curvature in the stack.

[0117] As mentioned previously, in some embodiments, the arms 30 aredeflectable to form a predetermined arrangement, such as previouslyillustrated in FIG. 3D. Typically, when forming the predeterminedarrangement, the arms 30 are steerable up until the formation of thepredetermined arrangement wherein the arms 30 are then restricted fromfurther deflection. FIG. 17 illustrates an embodiment of such an arm 30comprising a plurality of adjacent links 62 wherein the arm 30 issteerable to a predetermined arrangement. As shown, the distal end 34comprises a base 64 which deflects the distal end 34 outwardly and a tipsection 66 which deflects inwardly. Between the base 64 and tip section66 lies a spacer 68 which is rigid. The spacer 68 may be considered alarger elongate link or simply a straight section. Usage of such spacers68 is optional and may be used to create specific predeterminedarrangements. FIG. 17A is an enlarged view of the tip section 66 whichillustrates the shapes of the links 62 which are pivotally connected byhinge structures 100 formed into the links 62. Gaps 102 are present onopposite sides of the structures 100 to allow curvature of the distalend 34. The size of the gaps 102 will vary due to varying sizes andshapes of the links 64 so that closure of the gaps 102 forms a specificcurvature. This is most easily seen in FIGS. 17B-17C. FIG. 17Billustrates links 62 of the base 64 having varying shapes to create gaps102 of varying size. As shown, a pullwire 96 extends through the links62 along the gaps 102. Applying tension to the pullwire 96 draws thelinks 62 together to close the gaps 102 and to form a predeterminedcurve as in FIG. 17C.

[0118] The predetermined arrangement of FIG. 17 includes curvatures inopposite directions, the base 64 curving laterally outwardly and the tipsection 66 curving laterally inwardly. These distinct curvatures may beachieved by separate pullwires 96. For example, as shown in FIG. 18A, afirst pullwire 97 a may be positioned along one side of the tool arm 30terminating at a fixation point 104 a located midway along the distalend 34. The links 62 which lie proximally of this fixation point 104 aform the base 64. A second pullwire 97 b may be positioned along theopposite side of the arm 30 terminating at a fixation point 104 blocated at the tip of the distal end 34. Generally, the links 62 whichlie between the fixation point 104 a and the fixation point 104 b formthe tip section 66. Referring now to FIG. 18B, by applying tension tothe first pullwire 97 a, the base curves laterally outwardly, and byapplying tension to the second pullwire 97 b, the tip section curveslaterally inwardly.

[0119]FIG. 19 illustrates two tool arms 30 which are steered to apredetermined arrangement. Such steering is achieved with the use ofpullwires 96 as illustrated in FIGS. 18A-18B. Fixation points 104 b arevisible while fixation points 104 a are hidden within the arms 30. Asshown, the links 62 are varied in size and shape to form thisarrangement when tension is applied to the pullwires 96. For example,the links 62 are generally larger thought the bases 64 and smallerthrough the tip sections 66. Further, this embodiment includesstabilizers 120 which pass through the arms 30 for stability.

[0120] In some embodiments, the steerable distal end 34 includes bothtypes of links, links which are steerable to a predetermined arrangementand links which are unrestrictedly steerable. For example, FIG. 20illustrates an embodiment wherein the base 64 is comprised of links 62which are appropriately shaped and sized to deflect laterally outwardlyto form a predetermined arrangement. Such deflection is achieved with apullwire which is hidden from view and terminates midway along thedistal end 34. In this embodiment, the tip section 66 is comprised oflinks 62 which are appropriately sized and shape to deflect laterallyinwardly in an unrestricted fashion. The links 62 of the tip section 66are hinged together by pivot pins 106 to provide support throughout theunrestricted movement. In addition, a tool 40 having an end effector 48is shown passed through the tool deployment lumen 38 in the arm 30. Alsoshown in FIG. 20, the arms 30 are rotated to lie in different planes, afeature which has been described in previous sections.

[0121] It may be appreciated that the embodiments which include linksmay have any number of links. For example, the steerable distal end 34may have two links 62 which are hinged together by a hinge structure100. In this example, the shaft 36 would direct the first link 62 in afirst direction and the hinge structure 100 would turn the distal tip 16towards a second direction. The addition of more linkages 62 wouldcreate a smoother curve and/or allow multiple curves throughout thesteerable distal end 34.

[0122] Although the previous embodiments of the tool arms 30 have beencomprised of a plurality of adjacent links, it may be appreciated thatthe arms 30 may be comprised of material in any suitable form. Forexample, each arm 30 may be comprised of a polymeric tube which has beenpre-shaped, such as by heat setting, to form a desired curvature. Thepolymeric tube is comprised of a material which is sufficiently flexibleto allow straightening of the curve for delivery through the arm guidelumen 26 and adequately flexible to allow recoiling of the arm 30 toform the desired curvature upon emergence from the lumen 30.

[0123] In another embodiment, each arm 30 is comprised of a slottedtube, as illustrated in FIGS. 21A-21B. Referring to FIG. 21A, a tube 130has a series of slots 132 along its length. In this embodiment, theslots 132 are present along one side of the tube 130 however, it may beappreciated that the slots 132 may be present on both sides of the tubeor along any portion of the tube which is desired to deflect. Referringback to FIG. 21A, the pullwire 96 is positioned within the tube alongthe slots 132 and fixed to the tube 130 at a fixation point 104. Byapplying tension to the pullwire 96, the tube 130 is deflected towardthe pullwire 96 as shown in FIG. 21B. The presence of the slots 132allows the tube 130 to be comprised of a relatively rigid or thickmaterial while deflecting and curving with minimal buckling or impedanceby the tube 130. It may be appreciated that the tube 130 of FIGS. 21A-21B may alternatively be a solid-walled tube without slots comprised of athinner or more flexible material which itself allows deflection andcurvature with minimal buckling or impedance. Further, each of thefollowing embodiments illustrating various tool arms 30 may be comprisedof solid-walled or slotted tubes, or any other suitable tubeconstruction.

[0124] FIGS. 21C-21D illustrate an embodiment of the arm 30 comprised ofa tube 130 wherein a pullwire 96 is positioned on the outside of thetube 130 and fixed to the tube 130 at a fixation point 104. By applyingtension to the pullwire 96, the tube 130 is deflected toward thepullwire 96 as shown in FIG. 21D. Since the pullwire 96 is disposedoutside of the tube 130, the pullwire 96 forms a tether to the fixationpoint 104 and does not follow along the surface of the tube 130.

[0125] FIGS. 21E-21F illustrate an embodiment of the arm 30 comprised ofa polymer wall co-extruded with shape memory material, such as nitinolwire. FIG. 21E illustrates the arm 30 in a straightened position,wherein the arm 30 is passed through the arm guide lumen 26, and acurved position, wherein the arm 30 recoils to a shape-memory curve.FIG. 21F provides a cross-sectional view of the arm 30 of FIG. 21Eillustrating shape-memory material 280 distributed within the wall ofthe arm 30.

[0126] FIGS. 21G-21H illustrate an alternative mechanism for steeringthe tool arms 30. Referring to FIG. 21G, the shaft 20 of the main body10 is illustrated having a pair of tool arms 30 extending therefrom.Surrounding the arms 30 lies a deployment frame 290. The frame 290 iscomprised of a semi-rigid or rigid material, such as stainless steelwire, which provides sufficient strength to apply force to the arms 30.The frame 290 comprises at least two supports 292, each extending fromthe distal tip 16 of the shaft 20 and connecting at a peak 294. Eachsupport 292 attaches to a tool arm 30 at an attachment point 296. Theframe 290 also includes an actuation support 298 extending from thedistal tip 16 to the peak 294. The arms 30 and supports 292, 298 advancefrom the distal tip 16 of the main body 10 to a desired location in thebody in a straight configuration as illustrated in FIG. 21G. Referringto FIG. 21H, application of tension to the actuation support 298 drawsthe peak 294 toward the distal tip 16 causing the supports 292 to bow orbend outward drawing the attached arms 30 outward. Likewise, thesupports 292 may include hinges wherein the supports 292 would bend atthe hinge. Although FIG. 21H illustrates the arms 30 bending at theattachment points 296, it may be appreciated that the arms 30 may bendat any location. Such bending directs the tool deployment lumens 38toward each other to facilitate coordination of tools passedtherethrough. Movement of the peak 294 proximally and distally variesthe curvature of the arms 30 and provides steering. The frame 290 alsoserves to create a working space, restricting surrounding tissue fromencroaching on the arms 30 and tools 40.

[0127] In most embodiments, the distal ends of the tool arms arelockable to maintain a deflected position. Such locking may be achievedby any suitable mechanisms. When the tool arm is steerable bymanipulation of pullwires or pushwires, the wires may be held in placeto lock the distal end in a desired position. In embodiments comprisinga multiplicity of nestable elements through which pullwires pass, thepullwires are typically used to hold the elements in nesting alignmentand to provide steering and locking. By applying tension to thepullwires simultaneously, the elements may be compressed to a state inwhich they are locked by friction wherein the tension is held. Otherlocking mechanism may also be used. Further, the tool arms may be lockedrotationally and axially within the main body to maintain positioning ofthe tool arm in relation to the main body.

[0128] B. Shaft

[0129] As described previously, the shaft 36 of the tool arm 30 passesthough the main body 10. In embodiments wherein the main body 10 isdeflectable, the shaft 36 is also deflectable. However, although it isdesired that the shaft 36 be laterally deflectable, it is also desiredthat the shaft 36 maintain axial rigidity. Any suitable construction maybe used, including a braid reinforced torqueable tube. Additionalembodiments are described below.

[0130] FIGS. 22A-22B illustrate embodiments of the shaft 36 comprising acoil 140. Here, illustrated in FIG. 22A, the turns of the coil 140 lieadjacent to each other to prevent axial movement and maintain axialrigidity. However, the coil configuration allows deflection of the shaft36 as shown in FIG. 22B.

[0131] In another embodiment, illustrated in FIG. 23, the shaft 36comprises a plurality of adjacent linkages 150. Here, each linkage 150includes a pair of protruding structures 152 on its face and a pair ofnotches 154 on its base. The protruding structures 152 and notches 154are both arc shaped so that the protruding structures 152 of one linkage150 rotateably interfit with the notches 154 of an adjacently stackedlinkage 150. By alternating the position of the pairs of protrudingstructures 152 and notches 154 as shown in FIG. 23, the shaft 36 isflexible in both lateral bending directions while maintaining stiffnessaxially and in torsion. Also shown are flared lumens 158 which passthrough the protruding structures 152 and the wall of the shaft 36.Flaring allows for a rod or wire passed therethrough to move within thelumen 158 as a linkage 150 rotates over the protruding structure 152.Round pullwire lumens 156 pass through the notches 154 and the wall ofthe shaft 36 as shown. The rod or wire holds the linkages 150 in astacked configuration and optionally may be used to steer the shaft 36.

[0132] In another embodiment, illustrated in FIG. 24, the shaft 36comprises a plurality of adjacent linkages 160 which are also stacked toprovide lateral deflection while maintaining axial rigidity. Here, eachlinkage 160 includes a pair of protruding structures 162 on its face anda pair of notches 164 on its base. The protruding structures 162 andnotches 164 are both arc shaped so that the protruding structures 162 ofone linkage 160 rotateably interfit with the notches 164 of anadjacently stacked linkage 160. By alternating the position of the pairsof protruding structures 162 and notches 164 as shown in FIG. 24, theshaft 36 is flexible in both lateral bending directions whilemaintaining stiffness axially and in torsion. In this embodiment, thelinkages 150 include a central lumen 166 through which a rod or wire ispassed. The rod or wire is used to hold the linkages 60 in the stackedconfiguration.

[0133] C. Proximal End

[0134] The proximal end 32 of the tool arm 30 may simply terminate in anendpiece or connector for passage of a tool 40 through its tooldeployment lumen 38. However, the proximal end 32 may optionally includea steering cuff 35 for steering the tool arm 30, particularly forsteering its distal end 34.

[0135]FIG. 25A illustrates an embodiment of the proximal end 12 of themain body 10 wherein two tool arms 30 are present, each inserted throughan arm guide lumen 26 in the shaft 20 of the main body 10. As shown,each tool arm 30 includes a steering cuff 35 which remains outside ofthe main body 10 and the tool deployment lumen 38 is accessible throughthe steering cuff 35. FIG. 25B illustrates an alternative embodiment ofthe proximal end 12 wherein two tool arms 30 are present, each insertedthrough an arm guide lumen 26 through the handle 22 of the main body 10.Again, each tool arm 30 includes a steering cuff 35 which remainsoutside of the main body 10 and the tool deployment lumen 38 isaccessible through the steering cuff 35. This embodiment also includes alocking mechanism 170 on each arm 30. The locking mechanism 170 can bemanipulated, such as by turning a lever 172 shown in FIG. 25B, to lockthe distal end 34 or the tool arm 30 in a steered or deflected position.

[0136]FIG. 26 illustrates an embodiment of a steering cuff 35 disposedat the proximal end 32 of a tool arm 30 wherein a tool 40 is passedtherethrough. In this embodiment, the tool arm 30 includes fourpullwires 96 (three are visible in FIG. 26) which are equidistantlypositioned around the perimeter of the shaft 36. The pullwires 96 areused to steer the distal end 34 of the arm 30 as previously described.As shown, the tool 40 has a distal end 42 with an end effector 48 whichemerges from the distal end 34 of the arm 30. Likewise, the tool 40 hasa proximal end 44 which emerges from the steering cuff 35. In thisembodiment, the steering cuff 35 has a funnel shape wherein one end isattached to at least the pullwires 96 and typically additionally to thearm 30 itself. Deflection of the proximal end 44 of the tool 40,indicated by angular arrow 180, presses the proximal end 44 against thesteering cuff 35 which rotates the steering cuff 35 to a deflectedposition, indicated by dashed line. Such rotation applies tension topullwires 96 diametrically opposite to the deflected position asindicated by arrows 182. Such tension steers the distal end 34 of thearm 30. Thus, manipulation of the tool 40 within the steering cuff 35can be used to steer the distal end 34 of the arm 30.

[0137] FIGS. 27A-27B and FIGS. 28A-28B illustrate another embodiment ofa steering cuff 35. Here, the steering cuff 35 has a sphere shape and isdisposed at the proximal end 32 of the tool arm 30. The tool 40 ispassed through a lumen 184 in the sphere shaped cuff 35 so that thedistal end 42 of the tool emerges from the distal end 34 of the arm 30and the proximal end 44 remains outside of the cuff 35 as shown. In thisembodiment, the tool arm 30 includes four pullwires 96 (three arevisible) which are equidistantly positioned around the perimeter of theshaft 36. The pullwires 96 are used to steer the distal end 34 of thearm 30 as previously described. FIG. 27A illustrates the pullwires 96emerging from the shaft 36 of the arm 30 and attached to the surface ofthe sphere shaped cuff 35. Likewise, FIG. 27B provides a similar view,however in this case the arm 30 is cutaway to reveal the pullwires 96extending through lumens in the shaft 36 and the tool 40 extendingthrough the tool deployment lumen 38. FIG. 28A illustrates theembodiment in the straight position. Deflection of the proximal end 44of the tool 40, indicated by angular arrow 180, presses the proximal end44 against the steering cuff 35 which rotates the steering cuff 35 to adeflected position, as shown in FIG. 28B. Such rotation applies tensionto pullwires 96 diametrically opposite to the deflected position asindicated by arrow 182. Such tension steers the distal end 34 of the arm30. Thus, manipulation of the tool 40 within the steering cuff 35 can beused to steer the distal end 34 of the arm 30.

[0138] It may be appreciated that the embodiments of the steering cuff35 depicted in FIG. 26 and FIGS. 27A-27B, 28A-28B may include any numberof pullwires 96 for any desired level of steerability. For example, ineach embodiment, two pullwires 96 may be present disposed on oppositesides of the steering cuff 35 for movement of the steerable distal end34 of an arm 30 in a single plane. This would be the case for laterallystabilized arms 30.

[0139] IV. Tool

[0140] As mentioned previously, the system 2 also includes at least onetool 40. In some embodiments, the tool 40 may simply comprises an endeffector 48 positioned at the distal end of the tool arm 30 wherein theend effector 48 is operated by manipulation of mechanisms which extendthrough the arm 30. In other embodiments, each tool 40 includes a distalend 42, a proximal end 44 and an elongate shaft 46 therebetween to allowpassage through the tool deployment lumen 38 of the arm 30. The shaft 46is typically desired to be a torque-stable tube comprised of anysuitable material, such as a braid or coil-reinforced extrusion. Inthese embodiments, each tool 40 has an end effector 48 disposed at thedistal end 42 and optionally a handle 50 at the proximal end 44 formanipulation of the end effector 48 from outside the body. Thus, thetool 40 is advanced so that the end effector 48 emerges from the distalend 34 of the arm 30.

[0141] A wide variety of end effectors 48 may be used depending on theprocedure or tissue manipulations which are desired. For example, endeffectors 48 may include but are not limited to knives, needles,sutures, staplers, fasteners, clippers, electrosurgical or hemostaticcutters and coagulators, laser welders, cryosurgery instruments,secondary scopes, forceps, lasers hooks, tongs, graspers, retractors,probes, clamps, scissors, tissue approximation devices and suctionapplicators.

[0142]FIG. 29 illustrates an embodiment of a tool 40 having an endeffector 48 in the form of scissors 200. Scissors are one of the oldestsurgical instruments used by surgeons. Scissors are used to perform manytasks in open surgical procedure but its use in minimal access surgeryrequires greater skill. As shown, the scissors 200 includes two blades202, a fulcrum 204 and force applicators 206. The cutting force of thescissors 200 works on the law of lever. The force applied on the blade202 can be calculated by length of the force applicators 206 and forceapplied on the applicators 206. The scissors 200 of the tool 40 do notapply the exact law of lever because of the cylinder action of the longshaft 46, but the design of applicators 206 helps in the amplificationof force by lever action. When the blades 202 of the scissors 200 close,its sharp edges grind against each other and any tissue which comesbetween the blades of scissors will be cut.

[0143] The scissors 200 of FIG. 29 provide an example of straightscissors wherein the blades are straight. This is a widely usedinstrument for mechanical dissection in laparoscopic surgery. Othertypes of scissors include curved scissors 214, illustrated in FIG. 29A,wherein the blade 202 of the scissors 214 is slightly curved. In somecases curved scissors 214 are preferred because the curvature of theblade 202 of this scissors creates additional angles of manipulation andmay provide a better view through the scope. Other types of scissorsinclude serrated scissors 216 wherein serrated edges 218 prevent thetissue from slipping out of the blades 202. This may be useful incutting a slippery tissue or ligature. Still other types of scissorsinclude hook scissors 220 which encircle a tissue structure beforecutting. Since the tissue is held between its hooked blades, there isminimal chance of slipping. The hook scissor 220 is especially usefulfor cutting secured ducts or arteries. Likewise, the cutting of nervebundles in neurectomy becomes may benefit from the use of hook scissors220. Hook scissors 220 are also helpful in partial cutting of cysticducts for intra-operative cholangiography. Further, additional types ofscissors include microtip scissors 222. One of the main advantages ofmicrotip scissors 222 is to cut ducts partially for facilitatingcannulation. Likewise, this scissor 222 may be used for cutting thecystic duct for performing intra-operative cholangiogram. Exploration ofsmall ducts like common bile duct is very helpful with microtip scissors222 due to its fine small blades. Fine microtip scissors 222 are alsoavailable in curved form.

[0144]FIG. 30 illustrates an embodiment of a tool 40 having an endeffector 48 in the form of gator toothed graspers 230. These graspers230 have reverse angled teeth 232 which are capable of providing anaggressive grip on tissue. In addition, the graspers 230 are cupped toallow tissue to herniated when the tissue is compressed. Thus, thegraspers 230 may be useful for pelviscopy and handling fibrous ovariesand uterine tissue.

[0145]FIG. 31 illustrates an embodiment of a tool 40 having an endeffector 48 in the form of an articulatable grasper 236. The grasper 236includes an articulation section 238 between grasper jaws 240 and theshaft 46. This allows the grasper 236 to articulate in an additionaldegree of freedom relative to tool arm 30.

[0146] Embodiments of the tool 40 having an end effector 48 may be inthe form of various shaped retractors. Examples of such retractorsinclude an angled retractor 242, (FIG. 32), hooked retractors 244 (FIGS.33-34), a triangular retractor 246 (FIG. 35), and a circular retractor(FIG. 36), to name a few. Each retractor is flexible and allows formanipulation of organs and tissue structures.

[0147] V. Auxiliary Lumens

[0148] As mentioned previously, lumens in addition to the scope lumen 24and arm guide lumens 26 may be present within the main body 10 and maybe considered auxiliary lumens 58. Such lumens 58 may be used for anypurpose, such as irrigation, suction, insufflation, macerating,illuminating, grasping, or cutting to name a few, and are typically usedin conjunction with the arms 30 and/or tools 40 inserted through thearms 30 or positioned at the ends of the arms 30.

[0149] In one embodiment, illustrated in FIG. 37A, grasping hooks 310are inserted through a single auxiliary lumen or through separateauxiliary lumens 58 (shown) in the shaft 20. The grasping hooks 310 maybe comprised of any suitable material, such as shape-memory wire orshapeable polymer, that allows a hook shape to be formed once the hooks310 have emerged from the distal tip 16. In addition, the hooks 310 mayhave a pointed or sharp tip to assist in grasping or piercing tissue.Referring to FIG. 37B, the grasping hooks 310 may be used to grasp aportion of tissue T to create a plication or fold. The tool arms 30 maythen be extended on opposite sides of the folded tissue T to deploy afixation device 312 which will hold the plication in place. FIG. 37Cillustrates such a fixation device 312 comprising a tie 314 passingthrough the tissue T with anchors 316 positioned on either side of theplication. The tie 314 may be comprised of a suture, wire or rod, forexample, and the anchors 316 may be comprised of knots, disks orexpandable umbrellas, to name a few. Such plication procedures may beused for treating gastroesophageal reflux disease (GERD).

[0150] Alternatively, other tools may be passed through auxiliary lumens58 for similar or other purposes. For example, a corkscrew device 320(FIG. 38) or a grasper claw 322 (FIG. 39) may be passed through anauxiliary lumen 58 for grasping tissue T. Or, tissue T may be graspedwith a suction device. FIG. 40A illustrates a suction device 324 in anundeployed configuration. The suction device 324 comprises a deploymentsleeve 328 which houses an expandable funnel 326. Withdrawal of thedeployment sleeve 328 releases the funnel 326 allowing the funnel 326 toself-expand, as shown in FIG. 40B. The increased surface area of thefunnel 326 allows for adequate suction for grasping tissue T and holdingthe tissue T within the funnel 326.

[0151] It may be appreciated that tools 40 may alternatively be passedthrough an arm guide lumen 26 for use in conjunction with a tool arm 30passed through another arm guide lumen 26. For example, as illustratedin FIG. 41, a macerator 336 may be passed through an arm guide lumen 26for maceration of tissue T or a blood clot while a tool arm 30 is usedfor irrigation and aspiration. The macerator 336 macerates the tissue Tto form small particles which may be more readily aspirated. Further,irrigation through the arm 30 may be used to cleanse portions of thedevice. For example, as illustrated in FIG. 42, the arm 30 may besteered to face the scope 28 allowing irrigation to cleanse the scope 28thus improving viewing.

[0152] VI Torque Transmission

[0153] As mentioned previously, the system 2 of the present inventionincludes an elongated main body 10 having a proximal end 12 and a distalend 14 terminating in a distal tip 16. An embodiment of the main body 10was illustrated in various configurations in FIGS. 8A-8C utilizingsteering and/or locking. Steering and locking may be achieved by anysuitable mechanisms. In some embodiments, the shaft 20 comprises aplurality of adjacent links, such as nestable elements 260 illustratedin FIG. 9A. FIG. 9B provided an exploded view of the nestable elements260 of FIG. 9A, illustrating that the elements 260 are disposed so thata distal surface 262 of one element 260 coacts with a proximal surface264 of an adjacent element. And, each of the nestable elements 260includes one or more pullwire lumens 98 through which pullwires 96 pass.The pullwires 96 are used to hold the elements 260 in nesting alignmentand to provide steering and locking. Generally, the adjacent surfaces262, 264 are contoured to mate so that when the pullwires 96 arerelaxed, surfaces 262, 264 can rotate relative to one another. Thisallows the shaft 20 to form curvatures throughout its length in anydirection.

[0154] In addition to steering with the use of pullwires 96, the mainbody 10 can be manipulated by torqueing. Typically, the distal end 14 ofthe main body 10 is positioned within the body while the proximal end 12remains outside of the body. It is often desired to rotate the distalend 14 within the body by manually rotating the proximal end 12. Toachieve this effectively, the main body 10 should be capable ofeffectively transmitting torque. To achieve this, particularly throughportions of the main body 10 which include adjacent links, such asnestable elements 260, a torque transmitting feature may be included.

[0155] One such torque transmitting feature is illustrated in FIGS.43A-43F. FIGS. 43A-43F illustrate the use of a tooth and groove conceptto maintain alignment of the plurality of adjacent links at locationsalong its length. By maintaining alignment in particular locations,torque may be more easily transmitted while still allowing freedom ofrotation of the links for steering.

[0156]FIG. 43A is a perspective view of one of the plurality of adjacentlinks, a first link 500. The first link 500 has a top edge 502, a bottomedge 504, an outer surface 506 and an inner surface 508 forming a domedring-like structure having a lumen 505 therethrough. Pullwire lumens 98are shown passing through the inner surface 508 and out through the topedge 502. It may be appreciated that the pullwire lumens 98 may be usedfor other elements, such as support wires or rigidizing wires, howeverat least some of the pullwire lumens 98 are used for passing pullwires96 for steering. The first link 500 also includes a torque transmittingfeature comprising at least one protrusion, such as a tooth 510, whichprotrudes inward from the inner surface 508 in this embodiment. Thetooth 510 may have any suitable shape or size and may extend beyond theedges 502, 504. In this embodiment, the tooth 510 has a first tooth end512 and a second tooth end 514 wherein the first tooth end 512 is flushwith the inner surface 508 and the second tooth end 514 protrudesoutwardly toward the bottom edge 504 of the link 500 forming a wedgeshape. The torque transmitting feature also includes at least one groove516 in the outer surface 506. The groove 516 is sized, shaped andpositioned so that when the first link 500 is engaged with an adjacentlink, the groove 516 in the first link 500 accepts a tooth 510 on theadjacent link.

[0157] In some embodiments, a pair of teeth 510, 510′ are presentwherein one tooth 510 is located in a diametrically opposite positionfrom the other tooth 510′. Likewise, a pair of grooves 516, 516′ arealso present wherein one groove 516 is located in a diametricallyopposite position from the other groove 516′, or 180 degrees apart.Typically, the pair of teeth 510, 510′ and pair of grooves 516, 516′ arelocated so that each are separated by approximately 90 degrees, as shownin FIG. 43A. FIG. 43B provides a side view and FIG. 43C provides apartial perspective view of the link of FIG. 43A.

[0158] The first link 500 is engageable with a series or plurality ofadditional links, each having the same or similar features as the firstlink 500. Such a plurality of adjacent links is shown in FIG. 43D. Here,the first link 500 is shown mated with a second link 520, a third link522, a fourth link 524 and a fifth link 526. The links 500, 520, 522,524, 526 are each individually rotateable by steering, such as with theuse of pullwires 96 as described in related earlier sections. FIG. 43E,illustrates four of these links 500, 520, 522, 524 wherein the outersurface 506 of each link is mated with the inner surface 508 of anadjacent link along a longitudinal axis 530. The first link 500 is shownto have a pair of teeth 510, 510′, one tooth 510 disposed in a positionalong the inner surface 508 which is diametrically opposite to the othertooth 510′. The one tooth 510 is slidably engageable with a groove 516in the outer surface 506 of the adjacent second link 520 and the othertooth 510′ is slidably engageable with a groove 516′ in a diametricallyopposite position in the outer surface 506. In this embodiment, groove516 has a first groove end 518 and a second groove end 519. The grooveends 518, 519 are substantially aligned with the longitudinal axis 530to allow sliding of the tooth 510 along the groove 516 during rotationof the link away from the longitudinal axis 530. Likewise, groove 516′has a first groove end 518′ and a second groove end 519′ in a similararrangement.

[0159] The second link 520 also includes a pair of teeth 510, 510′ whichare each disposed 90 degrees from the grooves 516, 516′. Therefore, onlyone tooth 510 is visible in the second link 520 since the teeth 510,510′ aligned in the view of FIG. 43E, however it may be appreciated thateach of the pair of teeth 510, 510′ in the second link 520 are slidablyengaged with one of a pair of grooves 516, 516′ in the third link 522.Likewise, the third link 522 is shown to have a pair of teeth 510, 510′,one tooth 510 disposed in a position along the inner surface 508 whichis diametrically opposite to the other tooth 510′. The one tooth 510 isslidably engageable with a groove 516 in the outer surface 506 of theadjacent fourth link 524 and the other tooth 510′ is slidably engageablewith a groove 516′ in a diametrically opposite position in the outersurface 506.

[0160] Steering rotates at least some of the links away from thelongitudinal axis 530, such as illustrated in FIG. 43F. Here, the firstlink 500 is shown rotated along another axis 532 which forms an anglewith the longitudinal axis 530. Such rotation slides the one tooth 510on the first link 500 downward along the groove 516 in the second link520 while the other tooth 510′ slides upward along the groove 516′ inthe second link 520. Thus, the first link 500 is free to rotate in thisplane. It may be appreciated that each link is free to rotate in atleast a plane defined by the alignment of teeth and grooves. When theposition of such aligned teeth and grooves are varied along the lengthof the plurality of adjacent links, the links are able to rotate invarious directions.

[0161] In addition, torqueing of the plurality of adjacent links istransmitted through the aligned teeth and grooves. For example, byapplying torque to the fourth link 524, as indicated by arrow 534 inFIG. 43F, the fourth link 524 will rotate about the longitudinal axis530 until one of the grooves 516′ contacts the slidably engaged tooth510′ which transmits the torque to the third link 522. This transmissionis repeated through each of the links, transmitting torque to the firstlink 500.

[0162] Another embodiment of a torque transmitting feature isillustrated in FIGS. 44A-44D. FIGS. 44A-44D illustrate the use of a pinand slot concept to maintain alignment of the plurality of adjacentlinks at locations along its length. By maintaining alignment inparticular locations, torque may be more easily transmitted while stillallowing freedom of rotation of the links for steering. In addition, thepin and slot concept prevents disengagement of the adjacent links whilethe main body is unlocked. This further enhances torque transmission.

[0163]FIG. 44A is a perspective view of one of the plurality of adjacentlinks, a first link 500. The first link 500 has a top edge 502, a bottomedge 504, an outer surface 506 and an inner surface 508 forming a domedring-like structure having a lumen 505 therethrough. Although pullwirelumens are not shown, it may be appreciated that pullwire lumens may bepresent, for example passing through the inner surface and out throughthe top edge. It may also be appreciated that the pullwire lumens may beused for other elements, such as support wires or rigidizing wires,however at least some of the pullwire lumens are used for passingpullwires for steering. The first link 500 also includes a torquetransmitting feature comprising at least one protrusion, such as a pin550, which protrudes outward from the outer surface 506. The torquetransmitting feature also includes at least one slot 552, providing anopening between the inner surface 508 and the outer surface 506.

[0164] In some embodiments, a pair of pins 550, 550′ are present whereinone pin 550 is located in a diametrically opposite position from theother pin 550′. Likewise, a pair of slots 552, 552′ are also presentwherein one slot 552 is located in a diametrically opposite positionfrom the other slot 552′, or approximately 180 degrees apart. Typically,the pair of pins 550, 550′ and pair of slots 552, 552′ are located sothat each is separated by approximately 90 degrees as illuatrated.

[0165]FIG. 44B provides a side view of the first link 500 of FIG. 44A.Dimensions provided are related to an exemplary embodiment are notintended to be limiting. It may be appreciated that the pin 550 may haveany suitable shape or size and may be positioned anywhere along theouter surface 506. In this embodiment, the pins 550, 550′ each have acylindrical shape with a cross-sectional diameter of approximately0.0325 in. and each is positioned near the top edge 502. Each slot 552is sized, shaped and positioned so that when the first link 500 isengaged with an adjacent link, a slot 552 in the first link 500 acceptsa pin 550 on the adjacent link. Typically, each slot 552 is positionednear the bottom edge 504, preferably 0.010 in. from the bottom edge 504as illustrated in FIG. 44B. Also illustrated in FIG. 44B, each slot 552has a first slot end 554 and a second slot end 556, typicallyapproximately 0.090 in. apart. The slot ends 554, 556 are substantiallyaligned with the longitudinal axis 530 to allow sliding of the pin 550through the slot during rotation of the link away from the longitudinalaxis 530, as will be illustrated in FIGS. 44C-44D.

[0166]FIG. 44C illustrates the first link 500 engaged with a second link520 having the same or similar features as the first link 500. The links500, 520 are each individually rotateable by steering, such as with theuse of pullwires 96 (not shown) as described in related earliersections. As shown, the outer surface 506 of each link is mated with theinner surface 508 of an adjacent link along a longitudinal axis 530. Thefirst link 500 is shown to have a pair of slots 552, 552′, one slot 552which is visible in this view. Extending through the one slot 552 is apin 550 which protrudes from the outer surface 506 of the adjacentsecond link 520. It may be appreciated that the second link 520 also hasan additional pin 550′ which passes through slot 552′.

[0167] Steering rotates at least some of the links away from thelongitudinal axis 530, such as illustrated in FIG. 44D. Here, the firstlink 500 is shown rotated along another axis 532 which forms an anglewith the longitudinal axis 530. Such rotation slides one pin 550 on thesecond link 520 upward along the slot 552 in the first link 500 whileanother pin 510′ slides downward along the slot 552′ in the first link500. Thus, the second link 520 is free to rotate in this plane. It maybe appreciated that each link is free to rotate in at least a planedefined by the alignment of pins and slots. When the position of suchaligned pins and slots are varied along the length of the plurality ofadjacent links, the links are able to rotate in various directions.

[0168] In addition, torqueing of the plurality of adjacent links istransmitted through the aligned pins and slots. For example, by applyingtorque to the second link 520, the second link 520 will rotate about thelongitudinal axis 530 until one of the slots contacts the slidablyengaged pin which transmits the torque to the first link 500. Thistransmission may be repeated through any number of links, transmittingtorque through a plurality of adjacent links.

[0169] Another torque transmitting feature is illustrated in FIGS.45A-45C. FIGS. 45A-45C illustrate the use of a torque transmittingcovering over the plurality of adjacent links providing torquetransmission therethrough while the links are rotateable. FIG. 45Aillustrates an embodiment of the torque transmitting covering. In thisembodiment, the covering 570 comprises a sheath 576 havingreinforcements 578 throughout. Such reinforcements 578 are comprised ofnylon, polyurethane, polyethylene, Teflon, metal, polymer or anysuitable material and are typically braided or woven, however anyarrangement of the reinforcements 578 may be used. The reinforcements578 may be dipped in a polymer dispersion in a suitable solvent to coatthe reinforcements 578. Such coating holds the reinforcements 578together in a desired arrangement suitable for torque transmission.Alternatively or in addition, the reinforcements 578 may be sprayed,painted or otherwise coated with a polymer. Likewise, other methods offorming the covering 570 may be used. It may also be appreciated thatthe covering 570 may be formed without reinforcements 578. The coatingmay also be an independent component that is draped over thereinforcements 578.

[0170] The covering 570 may have any suitable size or shape, but istypically an elongate tube sized to fit snuggly around the plurality ofadjacent links which are rotateable relative to each other whenunlocked. Typically the covering 570 has a wall thickness in the rangeof approximately 0.005 to 0.015 in., typically in the range ofapproximately 0.010 to 0.015 in. Snug fit of the covering around theadjacent links prevents the links from disengaging while allowing thelinks to rotate during steering. Thus, the covering 570 may also beformed by dipping the adjacent links in a polymer dispersion to form acoating on the links.

[0171]FIG. 45B illustrates the covering 570 fit over a series orplurality of adjacent links (a first link 500, second link 520, thirdlink 522, fourth link 524 and fifth link 526) wherein the outer surfaceof each link is mated with the inner surface of the adjacent link alonga longitudinal axis 530. The links 500, 520, 522, 524, 526 are eachindividually rotateable by steering, such as with the use of pullwires96 as described in related earlier sections.

[0172] Torqueing of the plurality of adjacent links is transmitted withthe use of the covering 570. For example, by applying torque to thefifth link 526 and surrounding covering 570, as indicated by arrow 572in FIG. 45C, the fifth link 526 will rotate about the longitudinal axis530 along with the surrounding covering 570. The torqueing force appliedto the covering 570 will be transmitted along the length of the covering570 from the fifth link 526 toward the first link 500. Since thecovering 570 is snuggly fit around the links, the links will maintainengagement, assisting in the transmission of torque. Thus, the firstlink 500 will then rotate about the longitudinal axis 530, as indicatedby arrow 574, in response to the rotation of the fifth link 526.

[0173] Another torque transmitting feature is illustrated in FIGS.46A-46E. As mentioned, embodiments of the main body typically include aproximal end, a distal end and at least one lumen extending between theproximal and distal ends, at least a portion of the elongated main bodycomprising at least a first link and an adjacent second link which arerotateable relative to each other when unlocked. FIGS. 46A-46Dillustrate cross-sectional views of a link wherein one of the at leastone lumen extending through the links has at least one partition. Forexample, referring to FIG. 46A, a first link 500 is shown having lumen505 extending therethrough. The lumen 505 has two partitions 590, eachpartition 590 having the form of an inward protrusion. Any number ofpartitions 590 may be present, such as two, three, four, five, six,seven, eight or more. For example, FIG. 46B illustrates a first link 500having a lumen 505 with five partitions 590. In this example, thepartitions 590 provide the lumen 505 with a fluted shape. The partitions590 may have any shape, for example, blunt, pointed, rounded, or square,and may extend inwardly any distance. For example, FIG. 46C illustratesa first link 500 having a lumen 505 with partitions 590 which extendfurther into the lumen 505 than in the embodiments of FIGS. 46A-46B.Further, as illustrated in FIG. 46D, the partitions 590 may comprise atleast one divider 592 spanning across the lumen 505 of the link 500forming sub-lumens 594. In addition, also illustrated in FIGS. 46A-46D,the links 500 may also include other lumens, such as steering orpullwire lumens 98 for the passage of pullwires used in steering.

[0174] The partitions 590 are used as a torque transmitting feature withthe use of an elongated shaft 600 passing through the lumen 505, asillustrated in FIG. 46E. As shown, the first link 500 is engageable witha plurality of adjacent links, such as a second link 520 and third link522, each having the same or similar features as the first link 500. Inaddition, the links 500, 520, 522 are arranged so that the partitions590 within each link are generally aligned. The shaft 600 passes throughthe lumen 505 and is positioned between partitions 590 in each of thelinks. Torqueing of the plurality of adjacent links is transmittedthrough the shaft 600 and partitions 590. For example, by applyingtorque to the first link 500, the link 500 rotates about thelongitudinal axis 530 until the shaft 600 contacts a partition 590.Since the partitions 590 are generally aligned, the shaft 600 will alsocontact partitions 590 in the second link 520 and third link 522.Therefore, torque is transmitted from the first link 500 to the thirdlink 522. This transmission may be repeated through any number of links,transmitting torque through a plurality of adjacent links.

[0175] Another torque transmitting feature is illustrated in FIGS.47A-47B. As mentioned, embodiments of the main body typically include aproximal end, a distal end and at least one lumen extending between theproximal and distal ends, wherein at least a portion of the elongatedmain body comprises a plurality of adjacent links. FIG. 47A illustratesa section of adjacent links, including a first link 500, a second link520 and a third link 522, wherein the links have an oval cross-section.As mentioned previously, and illustrated in FIG. 2B, the links may havean oval shape for a variety of purposes, including providing for adesired arrangement of, for example, a scope 28 and optionally tool arms30 passing through lumen 505. The oval shape may also function as atorque transmitting feature. As shown in FIG. 47B, torqueing of thefirst link 500 rotates the first link 500 about the longitudinal axis530, as indicated by arrows 602. The first link 500 will contact thesecond link 522 due to the oval shape, as shown. This will cause thesecond link 522 to rotate, as indicated by arrows 604. Thus, torque istransmitted to the second link 522. This transmission may be repeatedthrough any number of links, transmitting torque through a plurality ofadjacent links.

[0176] Another torque transmitting feature is illustrated in FIGS.48A-48C. As mentioned previously, embodiments of the main body typicallyinclude a proximal end, a distal end and at least one lumen extendingbetween the proximal and distal ends, wherein at least a portion of theelongated main body comprises a plurality of adjacent links. Across-sectional view of one of these adjacent links, such as the firstlink 500, is shown in FIGS. 48A-48C, wherein each of the links have thesame or similar cross-section. The torque transmitting feature comprisesa plurality of wires or rods 620 extending through the adjacent links.FIG. 48A shows eight rods 620, symmetrically arranged around lumen 505.It may be appreciated, however, that the rods 620 may be present in anyarrangement. When torque is applied to a link which is adjacent to thefirst link 500, the rods 620 passing through the first link 500 transmitthe torque (indicated by arrows 622) to the first link 500 therebyrotating the first link 500. This transmission may be repeated throughany number of links, transmitting torque through a plurality of adjacentlinks. Similarly, FIG. 48B shows sixteen rods 620, symmetricallyarrangement around lumen 505. Again, when torque is applied to a linkwhich is adjacent to the first link 500, the rods 620 passing throughthe first link 500 transmit the torque (indicated by arrows 622) to thefirst link 500 thereby rotating the first link 500. Thus, the more rods620 present the higher the torque transmission. FIG. 48C showsthirty-two rods 620, symmetrically arrangement around lumen 505. Anynumber of rods 620 may be present, typically ranging from eight tosixty-four. It may also be appreciated that the rod 620 may be comprisedof any suitable material, such as metal, metal wire, polymer, nitinol,filament or fiber, to name a few. Also, some or all of the rods 620 maybe pushwires or pullwires 96.

[0177] Although the foregoing invention has been described in somedetail by way of illustration and example, for purposes of clarity ofunderstanding, it will be obvious that various alternatives,modifications and equivalents may be used and the above descriptionshould not be taken as limiting in scope of the invention which isdefined by the appended claims.

What is claimed is:
 1. An endoluminal system comprising: an elongatedmain body having a proximal end, a distal end sized for passage througha body lumen, and at least one lumen extending between the proximal anddistal ends; a torque transmitting feature which provides torquetransmission between the proximal and distal ends while the main body isunlocked and able to form a desired configuration; and a lockingmechanism which locks the main body in the desired configuration.
 2. Theendoluminal system of claim 1, further comprising a visualizing element.3. The endoluminal system of claim 2, wherein the visualizing element isintegral with the main body.
 4. The endoluminal system of claim 2,wherein the at least one lumen comprises a visualizing lumen and thevisualizing element is configured for passage through the visualizinglumen.
 5. The endoluminal system of claim 4, wherein the visualizingelement comprises an endoscope.
 6. The endoluminal system of claim 1,wherein the at least one lumen comprises an arm guide lumen.
 7. Theendoluminal system of claim 6, further comprising at least one tool armbeing adapted to extend through the arm guide lumen.
 8. The endoluminalsystem of claim 1, further comprising a steering mechanism which steersthe main body to the desired configuration while the main body isunlocked.
 9. The endoluminal system of claim 1, wherein at least aportion of the elongated main body comprises a plurality of adjacentlinks.
 10. The endoluminal system of claim 9, wherein the plurality ofadjacent links comprises at least a first link and an adjacent secondlink, the torque transmitting feature comprising a tooth from the firstlink slidably engageable with a groove in the adjacent second link. 11.The endoluminal system of claim 9, wherein the plurality of adjacentlinks comprises at least a first link and an adjacent second link, thetorque transmitting feature comprising a pin from the first linkslidably engageable with a slot in the adjacent second link.
 12. Theendoluminal system of claim 9, wherein the torque transmitting featurecomprises a fluted shape of the at least one lumen.
 13. The endoluminalsystem of claim 9, wherein the torque transmitting feature comprises anoval shape of the plurality of adjacent links.
 14. The endoluminalsystem of claim 13, wherein the torque transmitting feature comprises aplurality of rods extending through the adjacent links.
 15. Theendoluminal system of claim 14, wherein the plurality of rods comprisesapproximately 8 to 64 rods.
 16. The endoluminal system of claim 9,wherein the steering mechanism comprises at least one pullwire extendingthrough the plurality of adjacent links.
 17. The endoluminal system ofclaim 1, wherein the torque transmitting feature comprises a torquetransmitting covering over the main body extending between the proximaland distal ends.
 18. The endoluminal system of claim 17, wherein thetorque transmitting covering comprises a sheath having reinforcements.19. An endoluminal device comprising: an elongated main body having aproximal end, a distal end, and at least one lumen extending between theproximal and distal ends, at least a portion of the elongated main bodycomprising a plurality of adjacent engageable links; and a torquetransmitting feature which provides torque transmission by preventingdisengagement of the adjacent links while the main body is unlocked andable to form a desired configuration.
 20. The endoluminal device ofclaim 19, wherein the plurality of adjacent engageable links comprisesat least a first link and an adjacent second link, the torquetransmitting feature comprising at least one pin from the first linkslidably engageable with at least one slot in the adjacent second link.21. The endoluminal device of claim 20, wherein the at least one pincomprises a pair of pins, each pin extending outwardly from an outersurface of the first link in a diametrically opposite position from theother pin.
 22. The endoluminal device of claim 21, wherein the at leastone slot comprises a pair of slots, each slot configured to accept oneor the pair of pins passing therethrough.
 23. The endoluminal device ofclaim 22, wherein the first link comprises a first domed ring having theouter surface and the adjacent second link comprises a second domed ringhaving an inner surface, the outer surface of the first domed ringmateable with the inner surface of the second domed ring along alongitudinal axis, and the rings rotateable away from the longitudinalaxis.
 24. The endoluminal device of claim 22, wherein each slotcomprises an elongate opening between a first slot end and a second slotend, the slot ends substantially aligned with the longitudinal axis toallow sliding of the pins through the slots during rotation of the ringsaway from the longitudinal axis.
 25. The endoluminal device of claim 19,wherein the torque transmitting feature comprises a torque transmittingcovering over the plurality of adjacent engageable links to preventdisengagement of the adjacent links.
 26. The endoluminal device of claim19, further comprising a locking mechanism which locks the links in thedesired configuration.
 27. An endoluminal device comprising: anelongated main body having a proximal end, a distal end, and at leastone lumen extending between the proximal and distal ends, at least aportion of the elongated main body comprising a at least a first linkand an adjacent second link which are rotateable relative to each otherwhen unlocked; a torque transmitting feature comprising at least oneprotrusion from the first link slidably engageable with at least onegroove in the adjacent second link, the torque transmitting featureproviding torque transmission through the portion of the main body whilethe links are rotateable; and a locking mechanism which locks the linksupon actuation by preventing rotation of the links relative to eachother.
 28. The endoluminal device of claim 27, wherein the at least oneprotrusion comprises a pair of protrusions, each protrusion extendingoutwardly from an outer surface of the first link in a diametricallyopposite position from the other protrusion.
 29. The endoluminal deviceof claim 28, wherein the at least one groove comprises a pair ofgrooves, each groove configured to accept one or the pair of protrusionspassing therein.
 30. The endoluminal device of claim 29, wherein thefirst link comprises a first domed ring having the outer surface and theadjacent second link comprises a second domed ring having an innersurface, the outer surface of the first domed ring mateable with theinner surface of the second domed ring along a longitudinal axis, andthe rings rotateable away from the longitudinal axis.
 31. Theendoluminal device of claim 30, wherein each groove comprises a firstgroove end and a second groove end, the groove ends substantiallyaligned with the longitudinal axis to allow sliding of the protrusionsalong the grooves during rotation of the rings away from thelongitudinal axis.
 32. An endoluminal device comprising: an elongatedmain body having a proximal end, a distal end, and at least one lumenextending between the proximal and distal ends, at least a portion ofthe elongated main body comprising a plurality of adjacent links whichare rotateable relative to each other when unlocked; a torquetransmitting covering over the plurality of adjacent links providingtorque transmission therethrough while the links are rotateable; and alocking mechanism which locks the links upon actuation by preventingrotation of the links relative to each other.
 33. The endoluminal deviceof claim 32, wherein the torque transmitting covering comprises asnuggly fit sheath.
 34. The endoluminal device of claim 33, wherein thesheath includes reinforcements.
 35. The endoluminal device of claim 34,wherein the reinforcements comprises nylon, polyurethane, polyethylene,Teflon, metal, or polymer.
 36. The endoluminal device of claim 34,wherein the reinforcements have a braided or woven arrangement.
 37. Theendoluminal device of claim 34, wherein the reinforcements has beencoated with a polymer.
 38. The endoluminal device of claim 32, whereinthe torque transmitting covering comprises a polymer coating.
 39. Anendoluminal device comprising: an elongated main body having a proximalend, a distal end, and at least one lumen extending between the proximaland distal ends, at least a portion of the elongated main bodycomprising at least a first link and an adjacent second link which arerotateable relative to each other when unlocked, one of the at least onelumen extending through the links having at least one partition; anelongated shaft passing through one of the at least one lumen in amanner to transmit torque by contacting the least one partition; and alocking mechanism which locks the links upon actuation by preventingrotation of the links relative to each other.
 40. The endoluminal deviceof claim 39, wherein the at least one partition comprises an inwardprotrusion.
 41. The endoluminal device of claim 40, wherein the at leastone lumen extending through the links has a fluted shape forming theinward protrusions.
 42. The endoluminal device of claim 40, wherein theat least one partition comprises at least one divider spanning acrossthe one of the at least one lumen.
 43. The endoluminal device of claim39, wherein the at least one lumen includes at least one steering lumenthrough which a pullwire passes for use in steering the elongated mainbody.
 44. The endoluminal device of claim 43, wherein the at least onesteering lumen comprises a plurality of steering lumens around the oneof the at least one lumens.
 45. A method of accessing comprising:providing an elongated main body having a proximal end, a distal end, avisualizing element and a locking mechanism, wherein the main body iscapable of forming a desired configuration in an unlocked state andholding the desired configuration in a locked state; introducing themain body through a body passageway in the unlocked state forming thedesired configuration so that the distal end reaches a target location;actuating the locking mechanism to hold the main body in the desiredconfiguration; and viewing the target location with the use of thevisualizing element.
 46. A method as in claim 45, wherein introducingthe main body comprises allowing the main body to assume a shape of thebody passageway in the unlocked state forming the desired configuration.47. A method as in claim 46, wherein the main body comprises a pluralityof adjacent links and wherein actuating the locking mechanism comprisesholding the links in a fixed relation to each other.
 48. A method as inclaim 47, wherein the plurality of adjacent links comprises a pluralityof nestable elements and wherein holding the links comprises wedging thelinks together to hold them by friction.
 49. A method as in claim 45,wherein introducing the main body comprises steering the main bodythrough the body passageway in the unlocked state forming the desiredconfiguration.
 50. A method as in claim 49, wherein the main bodycomprises a plurality of adjacent links and wherein actuating thelocking mechanism comprises holding the links in a fixed relation toeach other.
 51. A method as in claim 50, wherein the plurality ofadjacent links comprises a plurality of nestable elements and whereinholding the links comprises wedging the links together to hold them byfriction.
 52. A method as in claim 45, wherein the main body includes atleast one lumen extending between the proximal and distal ends, andfurther comprising introducing an instrument through the at least onelumen.
 53. A method as in claim 52, wherein the instrument comprises atool arm.
 54. A method as in claim 45, wherein the elongated main bodyfurther includes a visualizing lumen and the visualizing elementcomprises an endoscope, the method further comprising positioning theendoscope within the visualizing lumen.